Computer System Validation (CSV) Engineer

Kashiv Biosciences LLC; Piscataway Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Kashiv Biosciences LLC in New Jersey is seeking an experienced CSV Engineer to support validation activities across regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. You will ensure systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA guidance.

You will collaborate with QA, IT, Lab, and Manufacturing to author and execute IQ/OQ/PQ protocols, manage risk and data integrity, and support audits

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).
• Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams.

Responsibilities

• Plan, author, and execute validation deliverables across assigned systems (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix).
• Support CSV activities across lab instruments, engineering and manufacturing equipment, and enterprise systems.
• 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 to drive consistent practices across sites.

Skills

CSV validation

Regulatory knowledge

Cross-functional collaboration

Risk assessments

Documentation

Education

Bachelor's degree in Life Sciences, Engineering, or IT

Tools

Caliber LIMS

SAP (QM/MM/PP)

CMMS/Calibration systems (BMRAM)

Job description

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
• Collaborate with senior validation leads and SMEs to drive consistent practices across sites

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)
• Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams

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

Work Environment & Physical Demands

• On‑site position
• Must be able to work extended hours or weekend hours, as may be required
• Moderate domestic travel may be required
• Noise: No extraordinary noise levels
• Standing/Lifting: Very unlikely, but may need to lift up to 20 lbs
• Visual: No extraordinary requirements
• Stress: High‑paced demanding environment to meet ambitious project goals