Lab Systems CSV Validation Engineer

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

Benefits offered by this job

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

Job summary

Cognizant seeks a CSV Validation specialist with pharma domain expertise in Rahway, NJ. Responsibilities include developing validation documentation for GMP/GLP environments, creating URS, IQ/OQ/PQ, RTMs, and ensuring regulatory compliance across CS artefacts.

Strong communication and technical writing skills are essential. The role emphasizes experience with FDA CFR 21 Part 11, EU Annex 11, GAMP 5, and SDLC; familiarity with lab systems, agile practices, and JIRA/ServiceNow is expected.

Qualifications

• Experience/ exposure to 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 have 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 SOPs; 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.
• 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.

Responsibilities

• 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.

Skills

CSV validation

Regulatory compliance

GAMP 5

CFR Part 11

Technical writing

Agile development

Jira/ServiceNow

AI awareness

Lab systems experience

Quality management

Tools

Jira

ServiceNow

HP ALM

Job description

Cognizant seeks a CSV Validation specialist with pharma domain expertise in Rahway, NJ. Responsibilities include developing validation documentation for GMP/GLP environments, creating URS, IQ/OQ/PQ, RTMs, and ensuring regulatory compliance across CS artefacts.

Strong communication and technical writing skills are essential. The role emphasizes experience with FDA CFR 21 Part 11, EU Annex 11, GAMP 5, and SDLC; familiarity with lab systems, agile practices, and JIRA/ServiceNow is expected.