We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
Essential Duties & Responsibilities- Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems
- Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), 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 SMEs to drive consistent practices across sites
Qualifications
- Bachelor's degree in Life Sciences, Engineering, or IT; or equivalent laboratory experience in a life sciences environment
- Minimum 5 years of CSV experience in a GxP‑regulated environment
- Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
- Hands‑on experience authoring and executing IQ/OQ/PQ protocols
- Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)
- Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams
Specialized Knowledge and Skills
- Familiarity with GAMP 5 principles and risk‑based validation
- Exposure to Caliber LIMS
- Exposure to SAP (QM, MM, PP) in a GxP context
- Experience with BMRAM or equivalent CMMS/calibration systems
Work Environment & Physical Demands
- On‑site position
- Must be able to work extended hours or weekend hours, as may be required
- Moderate domestic travel may be required
- Noise: No extraordinary noise levels
- Standing/Lifting: Very unlikely, but may need to lift up to 20 lbs
- Visual: No extraordinary requirements
- Stress: High‑paced demanding environment to meet ambitious project goals
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