Job Opportunities

Computer System Validation Engineer

Position: Computer System Validation Engineer
Work Location: Remote
Experience: 4+ Years
Notice Period: Immediate

Key Responsibilities:

• Should have 4+ years’ experience in computer system validation or testing experience in
the Life sciences domain.
• Provide application validation expertise on GxP products
• Good Knowledge of 21 CFR Part11, Annex11 and GAMP5
• Be accountable for authoring key CSV deliverables – URS/FRS, Validation Plan, RTM and
Validation Summary Report
• Requirements Analysis and Functional Risk Assessment, Profiling and Mitigation in
collaboration with the SME
• Reviewing and authoring of the Qualification scripts (IQ, OQ, PQ scripts, results and reports)
• Closely work with clients and product owners to support implementation and
resolve product issues.

Qualification:

• BE/B Tech/MC