Conduct cell culture process validation, including bioreactor qualification and semi-automated fill-finish operations.
Author and execute IQ, OQ, and PQ validation protocols (consultant must be proficient in writing, not just execution).
Perform CQV activities related to process equipment, qualification, CSV, and facilities/utilities validation.
Support semi-automated fill operations and ensure process compliance.
Work with upstream and downstream processing as well as automated fill-finish systems.
Validate and operate sealers and welders for biopharmaceutical applications.
Utilize advanced microscopy for real-time imaging and complex system analysis.
We are seeking a CQV Validation Consultant with hands-on experience in cell culture, bioreactors, and fill-finish operations to support clinical-phase validation activities.
The consultant will be responsible for developing and executing validation protocols to ensure compliance with industry standards and regulatory requirements.
Requirements:
Extensive hands-on experience in clinical-phase biopharmaceutical manufacturing (Gene Therapy experience is a plus, but biologics experience is acceptable).
Strong technical expertise in bioreactors, cell culture processes, and automation.
Proven ability to develop and execute validation protocols in a regulated.
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