Senior CSV Engineer: GxP Validation & Compliance

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

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