Senior Quality CSV Engineer
About The Position
Amneal is seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. The role serves as a liaison among Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements. The engineer plans, authors, and executes validation deliverables and supports systems in a validated state through change control and periodic reviews. The role also carries out risk and data-integrity assessments, supports audits and investigations, and collaborates with senior validation leads and subject-matter experts to promote consistent practices across sites.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or IT, or equivalent laboratory experience in a life sciences environment.
- At least 8 years of CSV experience in a GxP-regulated environment.
- At least 8 years of experience authoring and executing IQ/OQ/PQ protocols.
- Experience validating at least two of the following: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms such as BMRAM.
- Experience acting as a liaison across IT, Quality, Laboratory, and Manufacturing teams.
- Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance.
- Familiarity with GAMP 5 principles and risk-based validation.
Nice To Haves
- Exposure to Caliber LIMS and SAP (QM, MM, PP) in a GxP context.
- Experience with BMRAM or equivalent CMMS/calibration systems.
Responsibilities
- Plan, author, and execute validation deliverables, including validation plans, user requirements specifications, functional and design specifications, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
- Support CSV activities for laboratory instruments such as HPLC, GC, spectrophotometers, and balances; engineering and manufacturing equipment; and enterprise systems including Caliber LIMS, SAP, and BMRAM.
- Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review.
- Execute risk assessments and data-integrity assessments aligned with ALCOA+ principles.
- Support audits, inspections, CAPA investigations, and deviations related to computerized systems.
- Collaborate with senior validation leads and subject-matter experts to drive consistent practices across sites.
- Act as a liaison across IT, Quality, Laboratory, and Manufacturing teams.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
