CSV Lab Validation Engineer – GMP/GLP Systems

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

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.