Jamie McCain
Pharmaceutical Engineering | Facilities | Quality | Validation | Project Management | CSV
- Role
- Associate Director, Facilities Reliability at AskBio Inc.
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Jamie McCain
Performance-driven, multi-faceted, results-oriented equipment, facilities, and computer systems validation engineer in Biologics with experience in protein therapeutics and cell and gene therapy manufacturing processes. Proven track record of successfully identifying and remediating gaps in manufacturing operations; managing, maintaining, validating and qualifying highly technical production equipment per 21CFR p11. Consistently leverages strong expertise in maintenance, calibration equipment and software validation, and project/program management to successfully prepare for HA site visits and PAI Outstanding leadership, communication, and interpersonal skills combined with direct people management. Background of managing end-to-end project cycles, external vendors, operational excellence and capital projects, negotiating contracts and due diligence.
Experience
Associate Director, Facilities Reliability
Aug 2023 — Present · RTP, NC, US
Education
University of Wisconsin-Madison
Bachelor of Science - BS, Biological Systems Engineering
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