Sr Process Validation Engineer

Sr. Process Validation Engineer

Kelly® Science & Clinical is seeking a Sr. Process Validation Engineer for a Contract-to-hire position at a cutting-edge client in San Diego, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay: $150-160k Depending on experience

Schedule: Mon-Fri Onsite.

Overview

Our client is an industry-leading cell therapy company at the forefront of developing personalized, autologous cell therapies to treat neurodegenerative diseases. They are pioneering next-generation GMP manufacturing processes to bring life-changing treatments to patients.

The Sr. Process Validation Engineer will lead the development, implementation, and validation of complex manufacturing processes supporting the client’s cell therapy programs. This role operates with a high degree of autonomy, serving as a subject matter expert for fill/finish, container closure systems, and process validation activities across late-stage development and commercial readiness. You will partner cross-functionally with MSAT, Manufacturing, Facilities, Device, R&D, Regulatory, and Bioinformatics teams.

Responsibilities:

• Lead the development, execution, and maintenance of Master Validation Plans for GMP equipment and manufacturing processes, including authorship, review, and execution of IQ/OQ/PQ, PPQ, and related validation protocols in alignment with cGMP and regulatory expectations.
• Provide technical oversight for the installation, qualification, integration, and lifecycle management of new and existing process equipment supporting late-stage development and commercial readiness.
• Serve as subject matter expert for aseptic fill/finish operations for cell therapy drug products, including definition of critical process parameters and validation of associated processes.
• Lead the development, implementation, and validation of primary container closure systems (CCS), including design and execution of feasibility and development studies and collaboration with external CROs and testing laboratories.
• Act as a key technical stakeholder for container closure integrity testing (CCIT), including development, qualification, or adaptation of test methods where standard methods are not available.
• Integrate automated processing systems across all unit operations, including cell seeding, feeding, harvesting, filling, and cryopreservation.
• Lead development of secondary packaging solutions and support execution of shipping studies, stability programs, and technology transfer of validated processes to Manufacturing Operations.
• Generate, analyze, and interpret process and validation data to support regulatory filings, including BLA submissions.
• Partner cross-functionally with MSAT, Manufacturing, Facilities, Device, R&D, Regulatory, and other stakeholders to support system training, operational readiness, and continuous process improvement.

Qualifications:

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related discipline; advanced degree preferred.
• Minimum 5 years of progressive, hands-on experience in cell therapy, biologics, or biopharmaceutical manufacturing within a GMP environment.
• Demonstrated experience leading development, validation, and implementation of aseptic bioprocesses, with emphasis on fill/finish operations.
• Expertise in the design, execution, and documentation of qualification/validation protocols (IQ/OQ/PQ/PPQ) and development studies in GMP environments.
• Experience developing, validating, and supporting primary and secondary packaging systems, including container closure systems (CCS) and CCIT.
• Strong working knowledge of cGMPs, FDA and ISO standards, and quality management systems applicable to late-stage development and commercial manufacturing.
• Experience applying Design of Experiments (DoE) and statistical analysis tools (e.g., JMP or equivalent) to process development and validation activities.
• Strong written and verbal communication skills with demonstrated effectiveness in cross-functional, multidisciplinary teams and technical leadership without formal supervisory responsibility.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.