Validation engineer
Job in
Passaic, Passaic County, New Jersey, 07055, USA
Listed on 2026-07-20
Listing for:
Kasmo Global
Full Time
position Listed on 2026-07-20
Job specializations:
-
Engineering
Quality Engineering, Pharma Engineer, Regulatory Compliance Specialist, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
CQV Engineer
Design Documentation: URS, FRS, DS, and other engineering specifications
Validation Processes: IQ, OQ, PQ, Process Validation (PV), Computer Systems Validation (CSV), Master Validation Plan (MVP)
Quality Systems:
Change Control, Non-Conformances, Requalification protocols (IQ/OQ/PQ) in compliance with GMP, FDA, and other regulatory requirements
Regulatory Compliance:
Understanding of cGxP principles, ISO 13485, ISO 14971, and 21 CFR 820
CQV Leadership:
Leading CQV efforts for new and existing systems, troubleshooting issues, collaborating with cross-functional teams, preparing detailed validation documentation, and ensuring regulatory compliance
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