Must be authorized to work in the U.S. without sponsorship, now or in the future Position Summary 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 Collaborating with senior validation leads and SMEs to drive consistent practices across sites
Requirements:
Position Requirements and 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)
Experience:
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)
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 Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams
Work Environment & Physical Demands:
This is an on-site position Must be able to work extended hours or weekend hours, as may be required.
Noise:
No extraordinary noise levels.
Standing/Lifting:
Very unlikely, but can be able to lift at least 20 lbs.
Visual:
No extraordinary requirements.
Stress:
High-paced demanding environment to meet ambitious project goals.
