Validation Engineer - Autoclave​/Sterilization

Position: Validation Engineer - Autoclave / Sterilization
** Validation Engineer - Autoclave / Sterilization*
* *
* Location:

** Petaluma, CA

** Work Arrangement:
** Onsite

*
* Employment Type:

** Contract-to-Hire

** Pay Rate:**  $55-$68 per hour, depending on directly relevant autoclave validation experience, technical qualifications, and overall fit.

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.

** Qualifications*
* + 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.  ()  for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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