Lab System Validation Analyst

Job description

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Position Description:

CGI is seeking a detail-oriented and experienced Lab System Validation Analyst to support validation efforts for computerized laboratory systems in regulated (GxP) environments. This role is critical in ensuring lab systems meet regulatory requirements and perform reliably throughout their lifecycle. You’ll work closely with QA, IT, and Lab Operations to plan, execute, and maintain validation deliverables.

Location: Rahway - hybrid working model is acceptable.

Your future duties and responsibilities:

• Lead and execute computer system validation (CSV) activities for lab instruments, software, and analytical platforms (e.g., CDS, LIMS, ELN, SDMS).
• Author, review, and approve validation deliverables (e.g., URS, FRS, RTM, IQ/OQ/PQ protocols, validation plans, and reports).
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and relevant data integrity standards.
• Support risk assessments and impact analyses for system changes and new implementations.
• Partner with QA and Lab/IT stakeholders to define validation strategy, timelines, and resource needs.
• Maintain the validated state of systems through periodic reviews, audit support, and change control.
• Provide guidance and training to system owners and users on validation processes and regulatory requirements.
• Participate in vendor audits and qualification efforts where required.

Required qualifications to be successful in this role:

• 3-5 + years of experience in a GxP-regulated lab environment performing system validation or CSV.
• Familiarity with lab informatics systems such as Waters Empower, Agilent OpenLab, LabVantage, MasterControl, etc.
• Solid knowledge of regulatory requirements including GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles.
• Experience with documentation and testing tools such as HP ALM, ValGenesis, or similar.
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Preferred Skills:
• Experience in pharmaceutical, biotech, or medical device environments.
• Exposure to cloud-based lab systems and their validation considerations.
• Understanding of lab workflows and instrument qualification (IQ/OQ/PQ).
• Working knowledge of project management or SDLC methodologies (Agile, Waterfall).
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Soft Skills:
• Strong analytical thinking and attention to detail.
• Excellent communication and documentation skills.
• Ability to manage multiple priorities and collaborate across cross-functional teams.

Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.

Other Information:
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 $60,300.00 - $133,800.00.

CGI’s benefits are offered to eligible professionals on their first day of employment to include:
• Competitive compensation
• Comprehensive insurance options
• Matching contributions through the 401(k) plan and the share purchase plan
• Paid time off for vacation, holidays, and sick time
• Paid parental leave
•Learning opportunities and tuition assistance
• Wellness and Well-being programs

Skills:

·  Quality Assurance/QA Strategy

What you can expect from us:

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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 or responsibilities, reproductive health decisions, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics to the extent required by applicable federal, state, and/or local laws where we do business.

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.

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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. Dependent upon role and/or federal government security clearance requirements, and in accordance with applicable laws, some background investigations may include a credit check. 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.