Thinkinfinity
Avenel, NJ
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Job Description :
Role: System Validation Engineer
Location:- Raynham, MA

Job description:

B.S. /M.S. in IT/Engineering or equivalent with 5+years of experience in Computer System Validation with Life sciences – Pharma/ Medical Devices processes / projects especially-21 CFR part 11

Coordinate between Buyer stakeholders, Subject Matter Experts (“SME/s”)

Interact with Buyer, understand their requirement & provide delivery team with client expectations

Work closely with project leaders on collaborating and collecting the right inputs

Create and update documents relating to CSV activities per SDLC methodology.

Draft and maintain cGxP system lifecycle documentation, including validation plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), traceability matrix, validation reports, SOPs, change control documentation, risk assessments, and validation summary reports.

Reviewing completed protocols for completeness, cGxP compliance and data acceptability; compiles final data-pack.