Senior Quality CSV Engineer
About The Position
The Senior Quality CSV Engineer supports computer system validation activities across regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. The role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions to ensure systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements. The engineer plans, authors, and executes validation deliverables; supports risk and data integrity assessments; and helps maintain validated systems through change control and periodic review. The position also supports audits, inspections, CAPA investigations, and deviations related to computerized systems, collaborating with senior validation leads and subject matter experts to promote consistent practices across sites.
Requirements
- Bachelor’s degree (BA/BS) in Life Sciences, Engineering, or IT, or equivalent laboratory experience in a life sciences environment.
- Eight or more years of CSV experience in a GxP-regulated environment.
- Eight or more 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.
- 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 VP, URS, FS, DS, IQ/OQ/PQ, 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.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
