SQE Validation Lead (LabX)

Plymouth Meeting, PA

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:

Together, as owners, let’s turn meaningful insights into action.

Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you’ll reach your full potential because…

You are invited to be an owner from day 1 as we work together to bring our Dream to life. That’s why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company’s strategy and direction.

Your work creates value. You’ll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise.

You’ll shape your career by joining a company built to grow and last. You’ll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons.

Come join our team—one of the largest IT and business consulting services firms in the world.

Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, 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, 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 USEmploymentCompliance@cgi.com . You will need to reference the requisition number 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 requisition number 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 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.