Validation Engineer

Validation Engineer – Autoclave / Sterilization

Kelly Engineering is partnering with an established pharmaceutical manufacturing company to hire an experienced Validation Engineer specializing in autoclave or steam-sterilization systems
.

In this role, you will take ownership of qualifying and validating a newly installed autoclave that will be used to sterilize drug materials supporting clinical trials. You will lead the process from validation planning and load development through protocol execution, data analysis, and final reporting.

Candidates may come from an engineering or microbiology background, but direct 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.

• Lead the qualification and validation of a newly installed autoclave.
• Develop and execute applicable validation protocols, including IQ, OQ, and PQ activities.
• Determine appropriate load configurations and worst‑case 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 data and confirm consistent, repeatable sterilization performance.
• Investigate discrepancies and prepare GMP‑compliant documentation.
• Partner directly with company leadership and cross‑functional teams.

• 2‑4 four years of validation experience in pharmaceutical, biotechnology, medical device, or another regulated industry.
• Direct, hands‑on autoclave or steam‑sterilization validation experience—this is required.
• Experience with biological indicators, spore selection, load development, and sterilization‑cycle validation.
• Experience developing and executing validation protocols.
• Knowledge of IQ, OQ, PQ, and GMP requirements.
• An engineering, microbiology, biological sciences, pharmaceutical sciences, or related technical background.
• Strong technical writing, data‑analysis, and problem‑solving skills.
• Ability to independently manage a validation project from planning through completion.

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

If you have successfully validated autoclaves or steam‑sterilization systems in a GMP environment and are ready to take ownership of a critical pharmaceutical project, we would like to hear from you.