Position Details
About this role
This role involves leading validation activities for cell therapy manufacturing sites, ensuring compliance with GMP and regulatory standards, and managing lifecycle validation processes.
Key Responsibilities
- Establish validation strategies
- Oversee equipment and process validation
- Ensure regulatory compliance
- Manage validation lifecycle
- Maintain inspection readiness
Technical Overview
Focus on CQV, validation lifecycle, GMP compliance, and biologics manufacturing processes within a biotech environment.
Ideal Candidate
The ideal candidate is a senior validation expert with 8+ years of experience in cell therapy manufacturing, CQV, and GMP compliance. They should have a strong background in biologics and process validation, with excellent problem-solving and regulatory knowledge.
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 cell therapy or biologics, No GMP or validation background, Inability to work in a hybrid environment
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