CQV Engineer
Job in
Los Angeles, Los Angeles County, California, 90079, USA
Listed on 2026-03-01
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-03-01
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Biomedical Engineer, Quality Engineering -
Pharmaceutical
Validation Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
Seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical/biotechnology manufacturing environment. The role involves hands‑on execution of validation protocols, equipment qualification, and ensuring compliance with regulatory standards.
Required Experience- 3+ years of CQV experience in Pharma/Biotech GMP environment
- Hands‑on experience with Commissioning, Qualification (IQ/OQ/PQ), and Validation activities
- Experience with equipment qualification (upstream/downstream/process equipment, utilities, HVAC, clean rooms)
- Strong knowledge of cGMP, FDA regulations, and data integrity requirements
- Protocol authoring and execution (URS, FAT, SAT, IQ, OQ, PQ)
- Experience with process validation and cleaning validation
- Deviation management, CAPA, and change control experience
- Familiarity with Kneat, Veeva, or other validation documentation systems
- Author, review, and execute commissioning and qualification protocols (IQ/OQ/PQ).
- Support equipment, utility, and facility validation activities.
- Ensure compliance with FDA, cGMP, and regulatory requirements.
- Coordinate with engineering, manufacturing, and QA teams for validation deliverables.
- Manage deviations, change controls, and CAPA related to validation activities.
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