Job Type
Full-time
Description
Position Type: Full-time Employee (FTE)
Location: Piscataway, NJ (onsite - physical presence required)
Reports To: Sr. Director of IT
Work Authorization: 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.
Travel:
- Moderate domestic travel may be required.
