CSV Engineer

2 weeks ago


Pune, India Management and consulting solution Full time

Role Description This is a Project based role for a CSV (Computer System Validation) Engineer located in Pune. The CSV Engineer will be responsible for planning, executing, and maintaining validation processes for computer systems to ensure compliance with regulatory and industry standards. Daily responsibilities include drafting and reviewing validation documentation such as protocols and reports, performing risk assessments, and collaborating with cross-functional teams to ensure validated systems are fit for purpose. The role also involves troubleshooting issues, providing technical guidance, and ensuring that all validation activities are completed on time and within scope. Location: Pan India Experience: 1–6 Years Type of Employment: Contractual / Freelancing Industry: Pharma | Biotech | Life Sciences 🔹 Your Role: Draft & execute IQ/OQ/PQ validation deliverables for manufacturing, engineering, QC & enterprise systems (LIMS, MES, ERP, CDS, etc.) Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ Prepare & review validation documents (URS, FRS, RTM, Reports) Collaborate with QA, IT & Business Teams for smooth validation execution 🔹 You Bring: Degree in Computer Science / Engineering / Life Sciences / Pharmacy Strong knowledge of SDLC, risk-based validation, and QMS tools (TrackWise, Veeva, SAP) Excellent documentation & communication skills - (Preferred) Certifications: GAMP 5 / CSV / Six Sigma / PMP


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