Computer System Validation (CSV) Engineer

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.