Lab Equipment Validation SME

Plymouth Meeting, PA

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:

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, 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 USEmploymentCompliance@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.