Position Details
About this role
This role involves leading process validation activities at a cell therapy manufacturing facility, ensuring compliance with regulatory standards, and supporting technology transfer and facility start-up.
Key Responsibilities
- Lead process validation activities
- Perform data analysis and prepare validation reports
- Support equipment and facility commissioning
- Manage change controls and risk assessments
- Ensure inspection readiness
Technical Overview
The position requires expertise in biopharmaceutical process validation, cGMP, data analysis, and regulatory documentation, with a focus on cell therapy manufacturing.
Ideal Candidate
The ideal candidate is a senior-level process validation engineer with extensive experience in biopharmaceutical manufacturing, cGMP compliance, and validation activities. They possess strong leadership skills and a thorough understanding of regulatory requirements for cell therapy facilities.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in biopharmaceutical process validation, No familiarity with cGMP standards, No prior experience with regulatory inspections
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