Lab Systems CSV Validation Engineer (FDA 21 CFR Part 11)

Cognizant; California (MO); On-site; USD 75,000 - 123,000; 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 is seeking a CSV Validation Specialist to lead validation activities for pharmaceutical systems in GMP/GLP/GCP environments. You will craft validation plans, test protocols, URS/IQ/OQ/PQ, and traceability matrices while ensuring Regulatory compliance and quality management.

Experience with Lab systems and Ag ile practices is preferred. The role emphasizes documentation discipline, strong communication skills, and collaboration across QA, IT, and facilities teams within a US-based

Qualifications

• Experience/exposure to CSV, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• Experience of CSV Validation in Lab systems is must.
• Pharmaceutical domain 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 include validation plans, specifications, test protocols and SOPs for systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
• CSV, GAMP 5 CPFR Part 11, Validation, V model experience; SOP & SDLC lifecycle familiarity; CSA adaptation preferred.
• Provide guidance and leadership on Regulatory Compliance and Quality Management requirements.

Responsibilities

• Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix.
• Develop validation artefacts and ensure regulatory alignment.

Skills

CSV exposure

FDA Part 11

EU Annex 11

GAMP 5

Lab systems validation

GLP/GMP/GCP

Regulatory compliance

Agile development

Jira

ServiceNow

HP ALM

Tools

Jira

ServiceNow

HP ALM

Job description

Cognizant is seeking a CSV Validation Specialist to lead validation activities for pharmaceutical systems in GMP/GLP/GCP environments. You will craft validation plans, test protocols, URS/IQ/OQ/PQ, and traceability matrices while ensuring Regulatory compliance and quality management.

Experience with Lab systems and Ag ile practices is preferred. The role emphasizes documentation discipline, strong communication skills, and collaboration across QA, IT, and facilities teams within a US-based