Lab System Validation Engineer — CSV/GAMP 5 Expert

Cognizant; Mission (CA); On-site; USD 75,000 - 123,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Holidays

Paid Time Off

401(k) Plan

Disability Insurance

Parental Leave

Employee Stock Purchase Plan

Job summary

Cognizant is seeking a CSV validation specialist with pharma domain experience to lead validation efforts for process and lab automation, facilities and computerised systems in GLP, GMP and GCP environments.

You will prepare URS, IQ/OQ/PQ, TP and TS matrices, ensure regulatory alignment, and participate in audits while leveraging Jira/ServiceNow for tracking and collaboration.

Qualifications

• Experience with CSV validation and US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• Experience validating CSV in lab systems is a must.
• Pharma domain knowledge is required.
• Strong written and verbal communication skills are essential.
• Develop validation documentation for pharmaceutical equipment, facilities and computerized systems.

Responsibilities

• Prepare URS, MVP, VP, RTM, IQ, OQ, PQ, VSR and Traceability Matrix.
• Develop validation plans, specifications, test protocols and SOPs for validation projects.
• Lead validation activities across Process/Lab Automation, Enterprise IT and Network Infrastructure.
• Provide guidance on Regulatory Compliance and Quality Management requirements.
• Support regulatory audits and remediation activities.
• Collaborate with cross-functional teams using Agile methods and Jira/ServiceNow.

Skills

CSV validation

Regulatory compliance

Technical writing

Communication

Agile development

Education

Pharma domain experience

Tools

Jira

ServiceNow

HP ALM

Job description

Job Details:

• Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• Experience of CSV Validation in any one of the Lab systems is must.
• Should worked in pharmaceutical domain and its related knowledge is must
• Good communication and technical writing skills are a must
• Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
• CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
• To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
• Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
• Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
• Exposure to Regulatory Audits and Remediation activities
• Ensure the CSV artefacts are in line and meets regulatory requirements
• Preferred Experience in Agile Development
• Knowledge on working in Jira / Service Now
• Adaptation to AI is preferred.

Testing (in addition to above)

• Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
• Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.
• Knowledge on working in Jira, HP ALM or any automation testing tools.

*Please note this role is not able to offer visa transfer or sponsorship now or in the future*

We're excited to meet people who share our mission and who can make an impact in a variety of ways. Don't hesitate to apply—even if you only meet the minimum requirements. Think about your transferable experiences and unique skills that make you stand out.

Salary and Other Compensation:

Applications will be accepted until Sept 04, 2026,

The annual salary for this position is between $ 75,000 - $ 123,000 depending on experience and other qualifications of the successful candidate.

This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.

Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:

• Medical/Dental/Vision/Life Insurance
• Paid holidays plus Paid Time Off
• 401(k) plan and contributions
• Long-term/Short-term Disability
• Paid Parental Leave
• Employee Stock Purchase Plan

Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.