Validation Engineer – Autoclave/Sterilization
Listed on 2026-07-19
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Pharmaceutical
Validation Engineer, Quality Engineering, Pharma Engineer
Validation Engineer – Autoclave / Sterilization
Kelly Engineering is seeking an experienced Validation Engineer – Autoclave / Sterilization for an onsite opportunity with a pharmaceutical manufacturing company in Petaluma, California.
This individual will lead the validation of a newly installed autoclave that will be used to sterilize drug materials supporting clinical trials. Candidates may come from an engineering or microbiology background, but direct, hands-on autoclave or steam-sterilization validation experience within a GMP-regulated environment is required.
This is a contract-to-hire opportunity. The initial validation project is expected to take approximately two to three months, with the potential to transition into a full-time position based on performance and business needs.
Responsibilities- Lead the qualification and validation of a newly installed autoclave.
- Develop and execute applicable validation protocols, including IQ, OQ, and PQ activities.
- Establish load configurations and worst-case loading conditions.
- Select and use appropriate biological indicators and microbial spores.
- Conduct or oversee heat-distribution and heat-penetration studies.
- Establish and evaluate sterilization-cycle parameters.
- Analyze validation data and confirm consistent equipment performance.
- Investigate deviations and document findings and resolutions.
- Prepare validation protocols, final reports, and supporting documentation.
- Ensure validation activities comply with applicable GMP requirements.
- Work directly with company leadership and cross-functional stakeholders.
- Bachelor's degree in engineering, microbiology, biological sciences, pharmaceutical sciences, or a related discipline preferred.
- 2-4 years of validation experience in a regulated industry.
- Direct autoclave or steam-sterilization validation experience is required.
- Experience with biological indicators, microbial spores, load development, and sterilization-cycle validation.
- Experience developing and executing validation protocols.
- Knowledge of IQ, OQ, PQ, and GMP documentation.
- Strong technical writing and data-analysis skills.
- Ability to independently lead the validation process from planning through completion.
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