Jobshttps://cgi-veterans.jobs2024-03-26T00:06:45-04:00(USA-PA-Plymouth Meeting) Regulatory Consultant2024-03-26T00:06:45-04:00https://cgi-veterans.jobs/BEADE55DDC5D4A1A85A0A264F07D2E5626**Regulatory Consultant**
**Category:** Business Consulting, Strategy and Digital Transformation
**Main location:** United States, Pennsylvania, Plymouth Meeting
**Position ID:** J0324-1783
**Employment Type:** Full Time
**Position Description:**
The Regulatory Consultant will be a lead in driving and overseeing the delivery and consulting project within of CGIs key life science accounts and industry practices. Individuals filling the positions will have a unique opportunity to drive and assist in project and account growth. They will be responsible for strategic thinking and expert execution across the research organization including supporting their Regulatory Information Management portfolio of processes and systems serving Global Regulatory Affairs organizations and their partnering organizations. Partnering with business stakeholders as well as be a liaison with industry and business stakeholders to ensure activities are implemented to plans with Information integrity and according to defined requirements and timelines.
• This position will work with clients on both the business and IT organization to define, plan and execute strategic initiatives that will improve operational performance, increase profitability and create a competitive advantage. This role will lead initiatives across a variety of end-to-end solution offerings within the life sciences space.
We are looking for someone with the desire to drive innovation in the industry by collaborating with clients and industry partners to disrupt the current state of life sciences. This position will also be working with our industry leaders in building new capabilities and developing innovative ways for CGI to help its clients transform and grow.
**Your future duties and responsibilities:**
• Partners closely with our stakeholders to ensure fully integrated regulatory systems, experience and information model and externally facing capabilities.
• Improve quality of services, support colleagues and propagate knowledge and expertise
• Leverage engagement deliverables and project management experiences to form the basis of re-usable approaches and methodologies
• Lead and support development of market-leading capabilities related to area of expertise to support current and future needs within our Life Sciences clients
• Advise business stakeholders on mindset transformation and how their work will need to change to support the future.
• Serve as the bridge between the business and IT stakeholders to embrace technology as a tool to solve business problems.
• Support and guide clients to define, develop and plan various consulting engagements from short-term assessment projects to large-scale transformational initiatives.
• Define business needs and analyze complex problems. This includes but is not limited to scoping, requirements development, process development, communications, planning for individual efforts, managing, advising, overseeing implementations.
• Identify and document the needs of multiple stakeholders.
• Foster partnership with customers, stakeholders, sponsors.
• Qualifying opportunities and creating a strong business case to support recommendations..
• Build and maintain strong client relationships and develop business with assigned clients.
• Build and lead teams to foster individual and team development and expertise.
• Leverage CGI Operations Management standards to achieve targeted revenue and profitability.
**Required qualifications to be successful in this role:**
• Bring deep life science knowledge and delivery capability specifically around end to end Regulatory Operations (HRM, RIM, Submissions Planning, Publishing, Submissions Management), to be integrated into the market place and be responsible for bringing solutions and thought leadership to our clients, work well in collaborative environments, be highly motivated by delivering excellent services to our clients and ensuring their satisfaction.
• Will use and leverage your experience and creativity to design, propose and execute solutions for complex client problems in advanced business and technology environments.
• Manage client satisfaction in partnership with account management teams.
• Competency in Microsoft applications including Word, Excel, PowerPoint, MS Project, Visio.
• Strong experience with technology and IT organizations is important.
o (Agile / Scrum / Kanban principals)
• Strong Industry Practice knowledge in end to end Regulatory Operations (HRM, RIM, Submission
• Planning, Publishing, Submissions Management).
• System Implementation Experience with various industry vendors
•
Required Behaviors, Knowledge and Skills
• Lives up to the CGI Values: Partnership and Quality, Objectivity and Integrity, Intrapreneurship and Sharing, Respect, Financial Strength, Corporate Social Responsibility
• Demonstrates leadership: cultivates team spirit, provides direction and vision, displays integrity in action, fosters open communication
• Self-motivated with the ability to effectively multitask in a fast-paced environment.
• Minimum of 10+ years or equivalent experience in advising, defining, implementing and executing business processes change in the pharmaceutical industry, including an understanding of the drug development process.
• Experience with business systems use including content management systems, databases, business process management and electronic workflow/routing tools, regulatory submission, planning and tracking systems.
• Knowledge of application system management and change control processes, application validation and implementation in a GxP environment
• Knowledge of Pharmaceutical metadata and standards
• Demonstrated, in depth knowledge of Pharmaceutical drug development environment and regulations.
• Demonstrated customer relationship skills and capabilities and collaboration on teams.
• Demonstrated ability to perform in a cross-functional environment.
• Strong verbal, written communication and presentation skills.
• Ability to provide outstanding customer service, be a good listener and work well with others.
• Relevant project management delivery tools and techniques
• Analytical, problem solving, and conceptual thinking skills.
• Excellent written, verbal communication and negotiating skills, with customers, team and stakeholders
• Ability to influence stakeholders and work closely with them to determine acceptable future state offerings and solutions.
• Ability to effectively interface with technical and nontechnical staff at all organizational levels.
• Ability to learn new content areas and new skills quickly.
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $108,600 - $228,100.
At CGI we call our professionals “members” to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI’s benefits include:
• Competitive base salaries
• Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category
• 401(k) Plan and Profit Participation for eligible members
• Generous holidays, vacation, and sick leave plans
• Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment;
• Back-up child care, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more
\#LI-CG1
\#DICE
**Skills:**
+ Management Consulting
+ Life Sciences
+ Implementation Management
+ Regulatory Risk-Management
**What you can expect from us:**
**Insights you can act on**
While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees “members” because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today — one of the world’s largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI — where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned** .
We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.(USA-PA-Plymouth Meeting) Lab Computing Analyst2024-03-20T00:34:21-04:00https://cgi-veterans.jobs/1C6357B7651C40AF85D94A6873E593FB26**Lab Computing Analyst**
**Category:** Testing/Quality Assurance
**Main location:** United States, Pennsylvania, Plymouth Meeting
**Position ID:** J0324-1425
**Employment Type:** Full Time
**Position Description:**
CGI is seeking a seasoned Lab Computing Analyst to join our growing team supporting life science clients through end to end solution offerings and professional services. This individual must be able to work in a cross-functional environment and interact with representatives from CGI, and our end-clients. This lab Computing Analyst will work at various CGI/ clients consulting and executing various life science business and IT initiatives from infrastructure support, lab system support, shop floor, instrument integration and system processes expertise.
Location requirement: Client requires individual to be onsite in West Point, PA area (hybrid).
**Your future duties and responsibilities:**
-Incident Handling with respect to laboratory computers at the Facility (“Devices”) - request notification, service level thresholds and metrics reporting will utilize existing site processes and standards.
-Coordinate with relevant support teams and/or vendor to resolve issues
-In the cases where the issue requires coordination with other support teams, monitor the issue to closure
-Assist end users and vendors in the troubleshooting of software related to scientific applications.
-Project Support - Supporting activities related to IT projects in close collaboration with the local IT manage service team, as time allows.
-Commissioning – Installation of new Devices and required software.
-Communicate non-standard instrument requirements within IT – special operating system, networking, add-on hardware, storage, etc.
-Coordinate provision of / build standard Device with standard lab image or remediate vendor Devices (in compliance with client standards, or identify exceptions)
-Support purchases by client and install any add-on hardware such as additional RAM, NICs, network hubs, bar-code printers/scanners.
-Support network & instrument connectivity, including computer node name, addition to (“Active Directory”) policy group for instruments, resource account, share access, mounting of appropriate department shares.
-Coordinate and shadow vendor application software install and configuration with vendor as required.
-Enable instrument connectivity to the applications, and work through ServiceNow to submit software packaging requests for third-party applications.
-Provide connectivity to/for any printers, internal services or servers.
**Required qualifications to be successful in this role:**
-Computer, Software & Lab Deployment Tasks
-Networking & Infrastructure Experience
-Build client supplied computers to Lab Standards.
-Remediation of Vendor supplied computers to client Security standards.
-Application of client Overlay.
-Assist vendors with application, installation and / or configuration.
-Act as an IT Technical Resource(s) for GxP systems undergoing SDLC validations.
-Lock down of computer O/S to meet clients Data Integrity requirements.
-Verify systems comply with clients IT Security Standards for the lab environment
-Conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management. Confident and positive attitude, able to liaise with stakeholders at all levels and navigate company culture.
-Strong knowledge and understanding of business needs, with the ability to establish and maintain a high level of customer trust and confidence.
-Ability to manage internal and external projects from inception to successful implementation.
-Exceptional verbal and written communication skills; expertise in setting and managing customer expectations.
-Strong customer focus and ability to manage Client expectations
-Excellent communication and interpersonal skills.
-Strong organizational skills, able to make good decisions in a collaborative manner.
-Bachelor’s degree in fields associated to labs and quality control systems
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to: skill set level; experience and training; and licensure and certifications. CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $67,800.00-$228,100.00.
We offer a competitive compensation package where you’ll be rewarded based on your performance and recognized for the value you bring to our business. In addition, our benefits package includes multiple medical, dental, & vision options, both a Shared Purchase Plan (SPP) for CGI stocks and a 401(k) plan, as well as numerous other lifestyle benefits. CGI also provides sick leave and vacation pay.
\#LI-CG1
\#DICE
**Skills:**
+ Active Directory
**What you can expect from us:**
**Insights you can act on**
While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees “members” because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today — one of the world’s largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI — where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned** .
We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.(USA-PA-Plymouth Meeting) Business Solution Consultant2024-03-13T00:35:52-04:00https://cgi-veterans.jobs/9381763A78C64F8F8BF62F2B2560D97926**Business Solution Consultant**
**Category:** Business Consulting, Strategy and Digital Transformation
**Main location:** United States, Pennsylvania, Plymouth Meeting
**Position ID:** J0124-0942
**Employment Type:** Full Time
**Position Description:**
As an Business Solution Consultant, you are comfortable to engage with executives and are representing CGI and its unique value proposition in the context of our customers’ Life Science & Health industry environment. You are our customers’ trusted advisor, aligning our capabilities to their strategic goals and realizing significant value to our client base. You will blend deep process and industry expertise with a proven consulting skill set with strong analytical skills at the forefront of one of the fastest-growing tech companies worldwide. You enjoy not only excelling in business processes knowledge, but also the hands-on experience of knowing the software capabilities to put your advice into action.
This is a pipeline requirement for future hires expected in the second quarter of 2024. Candidates will be interviewed accordingly.
**Your future duties and responsibilities:**
- Be responsible for influencing and delivering the business process transformation strategy
and participate in value assessments projects
- Communicate value opportunity and roadmaps to our stakeholder base
- Advise on all aspects of value based contracting, deal modeling, and medical benefit
contracting strategies
- Influence and deliver business outcomes growth through innovative access strategies, new
market penetration and customer centric value programs
- Develop and maintain strong relationships with existing clients and become attuned to
potential business within the client
**Required qualifications to be successful in this role:**
- Three years experience (at a minimum) in Life Science Commercial operations, with a focus
on Managed Markets/Markets Access
- Specific expertise in Medical Benefits Contracting and Modeling
- Strong analysis, research, presentation (develop and deliver), and
documentation skills at the stakeholder level.
- Strong communication skills, both verbal and written, at all levels
- Analyzing data and making recommendations for pipeline prioritization
- Proven record of creating and maintaining business partnerships and relationships
- Strong decision making, judgment and analytical skills
- Demonstrated ability to effectively collaborate with cross-functional virtual teams
- Experience in gathering and documenting requirements, Business Process Analysis, &
Current/Future State Analysis
Soft Skills
- Consultative
- A “go getter” mentality – no sitting idle
\#LI-CG1
\#DICE
o CGI anticipates accepting applications for this position through 9/30/2024
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $85,800 - 165,200.
**Skills:**
+ Life Sciences
**What you can expect from us:**
**Insights you can act on**
While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees “members” because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today — one of the world’s largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI — where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned** .
We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.(USA-PA-Plymouth Meeting) Software Developer Intern2024-03-12T00:04:07-04:00https://cgi-veterans.jobs/B8499734B6ED4D60AB5473809AB2D52D26**Software Developer Intern**
**Category:** Software Development/ Engineering
**Main location:** United States, Pennsylvania, Plymouth Meeting
**Position ID:** J0324-0859
**Employment Type:** Student Internship
**Position Description:**
Launch a world-class career with our internships.
Are you fascinated by information technology and its role in innovative business solutions? Are you a collaborative problem solver eager to gain industry experience that can transform into a dynamic career in IT consulting? If so, an internship with CGI is just the place for you.
A typical day working as a Software Developer intern is exciting, filled with opportunities to learn, grow, and work in a collaborative setting to co-create and deliver successful solutions to our clients. When you join our program, you’ll have access to limitless upward mobility, opportunity and entrepreneurship. Here, you can explore your full potential – not confined by borders or pre-defined paths. You’re empowered to tackle problems and brainstorm ideas in your own unique way.
**Spring Application Period is from January 15, 2024 through March 31, 2024**
**Your future duties and responsibilities:**
How you’ll make an impact:
• Learn about our industry, customers, organization, and business objectives.
• Work alongside thought leaders to solve complex and critical challenges for our clients.
• Create systems design utilizing client requirements.
• Applications development and computer programming.
• Database maintenance and configuration management.
• Software installs, technical testing and reporting.
**Required qualifications to be successful in this role:**
What you’ll need:
• Enrolled in an accredited university/college pursuing a bachelor’s degree in a relevant field (i.e.: Computer Science, Computer Engineering or a similar major with extensive computer-based or technical content)
• A positive outlook and desire for learning
• Excellent problem solving, written and oral communication skills
• Flexibility and ability to deal with ambiguity
• Ability to work within a team environment
• Ability to work in the U.S. for an indefinite period of time
What you’ll gain:
• Industry experience
• Chance to provide influential assistance to projects and clients
• Involvement in a team-oriented atmosphere
• Involvement in the technical components of a client project
• Exposure to technical tools, technologies and cutting edge solutions
• Mentorship, guidance, and feedback
• Being a part of meaningful and practical work
The best version of you starts here
We’re a global company of owners. Over 90,000 members strong, we bring our diverse backgrounds and perspectives together to solve some of IT and business consulting’s toughest problems for some of the world’s best companies. Looking for a place that empowers you to explore your full potential and shape your own career? The scale and reach of our impact offer you just that. Join a team of great people, collaborate on meaningful work, and serve the communities you call home.
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set level, experience and training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $20.00 - $28.00 per hour.
\#LI-MT1
\#CGIEarlyCareers
**What you can expect from us:**
**Insights you can act on**
While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees “members” because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today — one of the world’s largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI — where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned** .
We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.(USA-PA-Plymouth Meeting) SQE Validation Lead (LabX)2024-03-06T00:26:11-05:00https://cgi-veterans.jobs/CB81F369574B42CC8F0D3B47EFB79F2726**SQE Validation Lead (LabX)**
**Category:** Software Development/ Engineering
**Main location:** United States, Pennsylvania, Plymouth Meeting
**Position ID:** J0324-0250
**Employment Type:** Full Time
**Position Description:**
CGI is seeking a seasoned validation software quality lead join our growing team supporting life science clients through end-to-end solution offerings and professional services. This must be able to work in a cross-functional environment and interact with representatives from CGI, and our end-clients. This validation engineer will work at various CGI/ clients consulting and executing various life science business and IT initiatives from validation planning, shop floor, instrument integration and system processes expertise.
**Your future duties and responsibilities:**
Quality Validation lead will possess strong analytical skills and detailed understanding of the solution validation processes across regulated and non-regulated systems. They objectively evaluate information gathered from multiple sources, reconcile conflicts, breakdown high level information into details, and abstract up low-level information to a general understanding distinguishing user request from the underlying needs of the business.
What you’ll be doing:
• Collaborates with clients, subject matter experts, and technical teams to execute the solutions validation deliverables for planning, development, and implementation and testing.
• Operate in Pharmaceutical QC Labs include Environmental Monitoring, Microbial, Bioburden, Virology, Sterility, Stability, Analytical, etc. Familiar with GMP lab processes and data capture with knowledge of regulatory considerations
• Contribute to the execution and documentation for deliverables such as Validation Master Plan, CSV Regulatory Risk Assessment, Validation Protocols (IQ, OQ, PQ), URS, FRS, Requirement Traceability Matrix (RTM), and Validation Summary Report.
• Demonstrates strong analytical skills and detailed understanding of solution validation processes including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.
• Serves as the conduit between the customer community (internal and external customers) and the services teams in which the validation deliverables flow.
• Documents complex business processes using a combination of diagrams and explanation.
• Identifies critical issues with ease.
• Assess and work with clients on quality management gaps, provide recommendations on remediation.
**Required qualifications to be successful in this role:**
• Strong understanding of any of the following : 21 CFR Part 11, 210, 211, 820(Quality System Regulations) , FDA, Risk Assessment, GAMP 5,SCADA Analysis, Remediation, Retrospective Validation, Change Control, CAPA.
• Expertise in QC testing, laboratory process, and experience within a pharmaceutical GMP compliant analytical lab.
• Successful individuals will have significant experience within the Bio-Pharmaceutical Manufacturing Laboratory domain.
• Knowledge of Quality & Lab Manufacturing (good manufacturing practices (GMP)) business process for biotech or pharmaceutical industry.
• Specific expertise with Document and Change control process is required Analyze and validate quality management business processes (e.g., developing quality manuals, interpretations of regulations, policies, and related quality management SOPs).
• Lab Software and Manufacturing Execution System Knowledge and Familiarity required; Mettler Toledo Systems (LabX) and or Werum MES
• Working Knowledge of Agile Scrum New Ways of Working & SDLC
Familiarity GxP Manufacturing Guidelines and/or GxP Quality Control / SCADA, Quality Assurance Experience Lab Equipment, Infrastructure
• Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management. Confident and positive attitude, able to liaise with stakeholders at all levels and navigate company culture.
• Strong knowledge and understanding of business needs, with the ability to establish and maintain a high level of customer trust and confidence.
• Ability to manage internal and external projects from inception to successful implementation.
• Familiarity with project management tools, methodology software development process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary validation testing methodologies and deployment management.
• Exceptional verbal and written communication skills; expertise in setting and managing customer expectations.
• Strong customer focus and ability to manage Client expectations.
• Excellent communication and interpersonal skills.
• Strong organizational skills, able to make good decisions in a collaborative manner.
• Bachelor’s degree in fields associated to labs and quality control systems.
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $76,300 - $228,100.
At CGI we call our professionals “members” to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI’s benefits include:
• Competitive base salaries
• Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category
• 401(k) Plan and Profit Participation for eligible members
• Generous holidays, vacation, and sick leave plans
• Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment.
• Back-up childcare, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more.
\#LI-CG1
\#Dice
**Skills:**
+ Life Sciences
+ Customer Interface Management
+ Scrum Master
**What you can expect from us:**
**Insights you can act on**
While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees “members” because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today — one of the world’s largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI — where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned** .
We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.(USA-PA-Plymouth Meeting) Software Quality Engineer2024-03-06T00:25:40-05:00https://cgi-veterans.jobs/6232512E25A24B67AAB96C7186B1E14C26**Software Quality Engineer**
**Category:** Software Development/ Engineering
**Main location:** United States, Pennsylvania, Plymouth Meeting
**Position ID:** J0324-0249
**Employment Type:** Full Time
**Position Description:**
CGI is seeking a seasoned MES software quality engineer to join our growing team supporting life science clients through end to end solution offerings and professional services. This person must be able to work in a cross-functional environment and interact with representatives from CGI, and our end-clients. This validation engineer will work at various CGI/ clients consulting and executing various life science business and IT initiatives from validation planning, shop floor, instrument integration and system processes expertise.
Location requirements: Must be able to work and travel to CGI and client sites in Plymouth Meeting, PA and West Point, PA.
**Your future duties and responsibilities:**
-Software Quality Engineers possess strong analytical skills and detailed understanding of the solution validation processes across regulated and non-regulated systems. They objectively evaluate information gathered from multiple sources, reconcile conflicts, breakdown high level information into details, and abstract up low-level information to a general understanding distinguishing user requests from the underlying needs of the business.
-Strong understanding of any of the following : 21 CFR Part 11, 210, 211, 820(Quality System Regulations) , FDA, Risk Assessment, GAMP 5,SCADA Analysis, Remediation, Retrospective Validation, Change Control, CAPA.
-Successful individuals will have significant experience within the Bio-Pharmaceutical Manufacturing Laboratory domain. Knowledge of Quality & Lab Manufacturing (good manufacturing practices (GMP)) business process for biotech or pharmaceutical industry. Specific expertise with Document and Change control process is required Analyse and validate quality management business processes (e.g., developing quality manuals, interpretations of regulations, policies, and related quality management SOPs). Assess and work with clients on quality management gaps, provide recommendations on remediation
What you’ll be doing:
-Collaborates with clients, subject matter experts, and technical teams to execute the solutions validation deliverables for planning, development, and implementation and testing. Expertise in QC testing, laboratory process, and experience within a pharmaceutical GMP compliant analytical lab. Operate in Pharmaceutical QC Labs include Environmental Monitoring, Lab Instrumentation, Bioburden, Virology, Sterility, Stability, Analytical, etc. Familiar with GMP lab processes and data capture with knowledge of regulatory considerations
-Design, develop and execute quality deliverables such as Validation Protocols, CSV Regulatory Risk Assessment, Validation Protocols (IQ, OQ, PQ),Change Controls, Hypercare and Validation Summary Report.
-Demonstrates strong analytical skills and detailed understanding of solution validation processes including a thorough understanding of how to interpret customer business needs and translate them into application and operational reports SOP and summaries
-Strong understanding of MES concepts, functionalities, and system integration principles. Must conduct testing,
troubleshooting, and ongoing maintenance of MES to ensure system reliability and accuracy of data.
-Familiarity with MES software platforms, such as Werum PAS-X, LabX or similar systems.
**Required qualifications to be successful in this role:**
REQUIRED QUALIFICATIONS TO BE SUCCESSFUL IN THIS ROLE
-Lab Software and Manufacturing Execution System Knowledge and Familiarity required; Mettler Toledo Systems (LabX) and or Werum MES
-Working Knowledge of Agile, Scrum, New Ways of Working & SDLC
-Familiarity with GxP Manufacturing Guidelines and/or GxP Quality Control / SCADA, Quality Assurance Experience Lab Equipment, Infrastructure
-Skilled in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management. Confident and positive attitude, able to liaise with stakeholders at all levels and navigate company culture
-Strong knowledge and understanding of business needs, with the ability to establish and maintain a high level of customer trust and confidence
-Ability to manage internal and external projects from inception to successful implementation
-Familiarity with project management tools, methodology software development process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary validation testing methodologies and deployment management
-Exceptional verbal and written communication skills; expertise in setting and managing customer expectations
-Strong customer focus and ability to manage Client expectations
-Excellent communication and interpersonal skills.
-Strong organizational skills, able to make good decisions in a collaborative manner
-Bachelor’s degree in fields associated to labs and quality control systems
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $76,300 - $228,100.
At CGI we call our professionals “members” to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI’s benefits include:
• Competitive base salaries
• Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category
• 401(k) Plan and Profit Participation for eligible members
• Generous holidays, vacation, and sick leave plans
• Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment;
• Back-up childcare, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more
\#LI-CG1
\#DICE
**Skills:**
+ Life Sciences
+ Customer Interface Management
**What you can expect from us:**
**Insights you can act on**
While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees “members” because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today — one of the world’s largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI — where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned** .
We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.(USA-PA-Plymouth Meeting) Project Manager / Product Owner2024-03-05T00:29:45-05:00https://cgi-veterans.jobs/C73B3B05D92147C28FB9FF04FFE642EE26**Project Manager / Product Owner**
**Category:** Project Management
**Main location:** United States, Pennsylvania, Plymouth Meeting
**Position ID:** J0324-0234
**Employment Type:** Full Time
**Position Description:**
CGI is seeking a seasoned project manager / product owner to join our growing team supporting life science clients through end to end solution offerings and professional services. The successful candidate must be able to work in a cross-functional environment and interact with representatives from CGI, and our end-clients. This project manager will work at various CGI/ client locations consulting and executing various life science business and IT initiatives from road map assessment architecture, best practice phase implementations, and go live.
Location requirements: Must be able to work and travel to Plymouth Meeting, PA and West Point, PA
**Your future duties and responsibilities:**
• Experience of 7-10+ years managing IT/Business projects in biotech and/or pharmaceutical industry
• Utilizing deep experience as both a Scrum / Coach (setting up new Agile teams from scratch), and (guiding and challenging leadership through lab transformations), to achieve meaningful business outcomes
• Contribute with specific expertise on Agile Methodology (Agile Ways of Working, Design Thinking, Scrum/Agile) into roadmap development approaches, the Lab Playbook and ongoing market engagement
• Participate and drive discussions with the various customer teams, to under IT Scope for Labs and MES Projects, and develop a detailed project plan.
• Manage the overall program success & monitor risk to the project. Status reporting to all stakeholders.
• Single point of contact acting as and IT Business Partner between various groups
• Manage high level escalation issues from the project teams
• Manage project success against financials, budget, scope and business objectives
• Drive the business requirements, validation plans, change management, training through workshops and meeting for Lab and MES next generation solutions delivery.
• Manufacturing Background project management experience lesioning with functional or technology stakeholders
• Excellent written and oral communication skills including capacity to comfortably interface with senior leaders, including executive staff
• Strong negotiation skills and ability to influence
• Strong organizational skills and multi-tasking capability, ability to function in a highly complex matrix organization
**Required qualifications to be successful in this role:**
• Lab Software and Manufacturing Execution System Knowledge and Familiarity required; Mettler Toledo Systems (LabX) and or Werum MES
• Working Knowledge of Agile Scrum New Ways of Working & SDLC
• Familiarity GxP Manufacturing Guidelines and/or GxP Quality Control / SCADA, Quality Assurance Experience Lab Equipment, Infrastructure
• Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management. Confident and positive attitude, able to liaise with stakeholders at all levels and navigate company culture
• Strong knowledge and understanding of business needs, with the ability to establish and maintain a high level of customer trust and confidence
• Ability to manage internal and external projects from inception to successful implementation
• Familiarity with project management tools, methodology software development process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary validation testing methodologies and deployment management
• Exceptional verbal and written communication skills; expertise in setting and managing customer expectations
• Strong customer focus and ability to manage Client expectations
• Excellent communication and interpersonal skills.
• Strong organizational skills, able to make good decisions in a collaborative manner
• Bachelor’s degree in fields associated to labs and quality control systems
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $67,800 - $228,100.
At CGI we call our professionals “members” to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI’s benefits include:
• Competitive base salaries
• Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category
• 401(k) Plan and Profit Participation for eligible members
• Generous holidays, vacation, and sick leave plans
• Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment;
• Back-up childcare, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more.
Skills:
Life Sciences
Customer Interface Management
\#LI-CG1
\#DICE
**Skills:**
+ Life Sciences
+ Project Management
**What you can expect from us:**
**Insights you can act on**
While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees “members” because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today — one of the world’s largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI — where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned** .
We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.(USA-PA-Plymouth Meeting) Lab Equipment Validation SME2024-03-05T00:25:03-05:00https://cgi-veterans.jobs/E5D0A89B4C6E4A71898D71FEA10CB41226**Lab Equipment Validation SME**
**Category:** Testing/Quality Assurance
**Main location:** United States, Pennsylvania, Plymouth Meeting
**Position ID:** J0324-0235
**Employment Type:** Full Time
**Position Description:**
The Lab Equipment Validation SME will specifically be a member of the CGI Life Science Industry Practice and will be preparing manufacturing and research sites for converting processes, analyses, and master data to new equipment and systems for next generation LabX environment.
**Your future duties and responsibilities:**
• Provides subject-matter expertise and support to medical science instrumentation and lab systems equipment as needed. This would include the complete array of lab systems equipment, Spectrometer, Chromatography, Sensors, Scanners, Meters, Stirrers etc.
• Develop close working relationships with all various quality and labs teams from management downstream to hyper care support teams
• Manage and lead all site validation activities along with the calibration and validation of test and data analysis equipment and systems used for equipment validation, change controls, and remediation.
• Lab Software and Manufacturing Execution System Expertise and Familiarity required; Mettler Toledo Systems (LabX is a must) and or Werum MES, shop floor instrumentation, quality labs optimization, labs stand-ups, infrastructure, integrations, validation, procedures and training
• Translate business process & technical alignment (including gap-analysis) requirements into qualification/validation test design documents and plans
• Familiar with software deployment and development life cycles. Possess excellent customer consulting, written and communication skills.
• Understand and make recommendation to the system processes, environments, SOPs, training and procedures
• Document system and use processes and business continuity procedures for Customer review and approval
• Provisioning users on systems undergoing validation and document steps
• Track down root cause of errors during qualification and testing of systems undergoing validation activities and document solutions
• Assist with system configuration and changes as directed by Client Lead and document results/procedure to configure
• Demonstrates facility in client-facing activities including:
• Eliciting and documenting business requirements.
• Analyzing and validating business requirements.
• Translating business requirements into system and non-functional requirements.
• Facilitating requirements review sessions with business and IT.
• Assists business clients with developing new business processes or modifying existing business processes (during implementation, may help develop communication material; define supporting procedures and standards; document training materials; assist in the immediate training effort; etc.).
• Assists in the creation of business cases and other related financial planning, impact identification, or value justification.
• Adheres to Solution Delivery Lifecycle (SDLC) and Agile Scrum New Ways of Working principles
• Develops the right skills to meet the future needs of the organization.
**Required qualifications to be successful in this role:**
• Lab Software and Manufacturing Execution System Expertise and Familiarity required; Mettler Toledo Systems (LabX is a must) and or Werum MES, shop floor instrumentation, quality labs optimization, labs stand-ups, infrastructure, integrations, validation, procedures and training
• Working Knowledge of Agile Scrum New Ways of Working & SDLC
• GxP Manufacturing Guidelines and/or GxP Quality Control / SCADA, Quality Assurance Experience.
• Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management. Confident and positive attitude, able to liaise with stakeholders at all levels and navigate company culture
• Strong knowledge and understanding of business needs, with the ability to establish and maintain a high level of customer trust and confidence
• Ability to support internal and external projects from inception to successful implementation
• Familiarity with software development process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary testing methodologies and deployment management
• Exceptional verbal and written communication skills; expertise in setting and managing customer expectations
• Strong customer focus and ability to manage Client expectations
• Excellent communication and interpersonal skills.
• Strong organizational skills, able to make good decisions in a collaborative manner
• Bachelor’s degree in fields associated to labs and quality control systems
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $67,800 - $228,100.
At CGI we call our professionals “members” to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI’s benefits include:
• Competitive base salaries
• Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category
• 401(k) Plan and Profit Participation for eligible members
• Generous holidays, vacation, and sick leave plans
• Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment;
• Back-up childcare, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more.
**Skills:**
+ Life Sciences
+ Customer Interface Management
**What you can expect from us:**
**Insights you can act on**
While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees “members” because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today — one of the world’s largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI — where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned** .
We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.