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CSV Engineer
Job in
Costa Mesa, Orange County, California, 92626, USA
Listed on 2025-12-02
Listing for:
Katalyst CRO
Full Time
position Listed on 2025-12-02
Job specializations:
-
Manufacturing / Production
Systems Engineer, Quality Engineering
Job Description & How to Apply Below
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Roles & Responsibilities- Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
- 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.
- Direct experience with GxP equipment, IT systems, or manufacturing automation systems.
- FDA and cGMP regulations and documentation practices.
- GAMP 5 guidance.
- 21 CFR Part 11 and Annex 11.
- Computer system validation methodologies.
- Familiarity with risk-based validation execution strategies.
- Strong technical writing skills with attention to detail.
- Experience authoring SOPs for laboratory or manufacturing equipment.
- Familiarity with LIMS, MES, SCADA, or laboratory instrumentation.
- Prior exposure to audits or regulatory inspections.
- Ability to manage multiple projects under tight deadlines.
Referrals increase your chances of interviewing at Katalyst CRO by 2x
Irvine, CA $-$
Seniority levelMid-Senior level
Employment typeContract
IndustriesPharmaceutical Manufacturing
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