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Validation Lead III-Process Engineer


Job Title:Validation Lead III-Process Engineer

Duties:
Provide scientific and engeinering expertise to suppor the process definition and design for a new flu drug substance manaufacturing facility.
Ensure that the process transferred into new facility performs to expectations, demonstrates consistency and robustness.
Ensure resulting process is sustainable, reliable and compliant with GMP standards.
Interface with scientific subject matter experts and engineering design tram for a new facility, providing technical rationale for process design criteria and user requirement specifications.
Contribute techncial expertise for the engineering design team, contributing to or reviewing documentation such as Process Flow Diagrams, Function requirements specifications and P&IDs.
Support the equipment design and selection efforts, including specification packages, factory and site acceptance testing to ensure that equipment will meet process validation requirements.
6-9 years experience required
Skills:
MS Office 2010 or later
Previous process validation and process design experience in a biologic or vaccine industry a must.

Education:
BS/MS in Chemical Engineering or bio Engineering a must

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