CQV Engineer
Job in
Los Angeles, Los Angeles County, California, 90079, USA
Listed on 2026-02-28
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-02-28
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Validation Engineer
Job Description & How to Apply Below
Roles & Responsibilities
- Lead qualification of cleanroom facilities and large-scale manufacturing process equipment, including centrifuges and filter presses
- Author, execute, and close validation protocols and final reports with minimal oversight
- Conduct construction walks, pre-check P&IDs, and identify, communicate, and elevate field and design issues
- Review and approve protocols, SOPs, TOPs, and vendor submittals against specifications and quality standards
- Drive execution planning, scheduling, and cross-functional coordination using Delta
V, Kneat, Veeva, Bluebeam, and MS365
- Bachelor's degree in engineering, Life Sciences, or a related field
- 3+ years of experience in validation within a regulated industry (e.g., pharma, biotech)
- Proven experience qualifying cleanroom facilities and manufacturing-scale process equipment
- Direct experience with centrifuges and filter presses at production scale (laboratory-only experience is not sufficient)
- Strong understanding of P&IDs and ability to interpret and verify in the field
- Demonstrated experience writing and executing validation protocols and authoring final reports
- Experience working in active construction and classified cleanroom environments
- Must be willing to be on-site, full-time in Los Angeles, CA
- Must be able (with 3-5 days' notice) to work any shift
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