Unknown Company

Senior CSV Engineer — GMP Validation Lead

harvard, ma • Posted 6 days ago
Onsite Full Time Bio & Pharmacology & Health

Verista, Inc. in Devens, MA is seeking a Senior CSV/CSA Engineer to lead validation of standalone bioprocess equipment using UNICORN, KlariFi and Lucullus software, not integrated with DeltaV.

You will own the CSV lifecycle and coordinate with Process Engineering, CQV, Automation, Quality, IT and vendors. You will develop validation plans, assess architecture, review specifications, and execute risk-based test protocols while ensuring 21 CFR Part 11 and EU Annex 11 compliance.

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