KB
Computer System Validation (CSV) Engineer
Accepting applicationsKashiv BioSciences LLC · Piscataway, NJ
Full-Time Mid_senior aiatesic
Posted
3d ago
Category
Test
Experience
Mid_senior
Country
United States
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.
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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.
Show more Show less