Lab system validation engineer (Onsite)

Cognizant; Rahway (NJ); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical/Dental/Vision/Life Insurance

401(k) plan and contributions

Paid holidays plus Paid Time Off

Long-term/Short-term Disability

Paid Parental Leave

Employee Stock Purchase Plan

Job summary

Cognizant is seeking a CSV validation specialist in Rahway, NJ to lead validation efforts for pharmaceutical equipment, facilities, and computerized systems in GMP/GxP environments. You will develop validation plans, write protocols, and ensure regulatory alignment with 21 CFR Part 11, EU Annex 11, and GAMP 5.

You will collaborate with cross‑functional teams, manage URS/IQ/OQ/PQ/VSR artifacts, and support audits, with Agile experience preferred. Salary aligns with market norms for the US region.

Qualifications

• Must have CSV validation experience in pharma domain.
• Experience validating Lab systems is required.
• Strong written and verbal communication skills.
• Experience creating URS, IQ, OQ, PQ, and VSR artifacts.
• Familiarity with Jira/ServiceNow and QA tools.
• Experience with Agile development is preferred.
• Exposure to regulatory audits and remediation activities.
• Knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5.

Responsibilities

• Develop validation documentation for pharmaceutical equipment, facilities, and computerized systems.
• Create validation plans, specifications, test protocols, SOPs, and traceability matrices.
• Ensure CSV artefacts meet regulatory requirements.
• Provide guidance on Regulatory Compliance and Quality Management.
• Lead migration due diligence for GXP and non-GXP areas.
• Collaborate with cross-functional teams and manage QA artifacts.
• Support audits and remediation activities.

Skills

CSV validation experience

GAMP 5

21 CFR Part 11

Regulatory compliance knowledge

Agile development

Excellent communication

Quality writing

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*

Salary and Other Compensation:

Applications will be accepted until Sept 27, 2026,

The annual salary for this position is between $ 75,000 - $ 95,000 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:

• 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.