Validation Engineer - Autoclave / Sterilization

Job Description

Job Description

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. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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