Biological Product Validation Specialist
OR
Last updated on 05 Feb 2026
Overview
A Biological Product Validation Specialist ensures that biological products, such as vaccines, cell therapies, and biologics, are consistently produced and controlled to meet quality, safety, and regulatory standards. They lead validation of equipment, processes, and analytical methods used in biologics manufacturing.
Job Description
- Plan, execute, and document validation activities for equipment, manufacturing processes, and analytical methods used in biological product production.
- Develop validation protocols (IQ, OQ, PQ) and reports in compliance with global regulatory requirements (FDA, EMA, WHO).
- Collaborate with cross-functional teams (QA, QC, Manufacturing, R&D) to ensure validation requirements are met.
- Conduct risk assessments and troubleshoot validation issues to ensure robust and compliant processes.
- Stay updated on emerging validation trends and regulatory expectations specific to biological product manufacturing.
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