A B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical engineering or related engineering field and 10 years of appropriate CQV experience in a cGMP manufacturing environment.
Additional experience and qualification requirements include the following:
• Extensive knowledge of validation activities, including protocol generation, execution and final report approval/closeout.
• Extensive knowledge of change control and performing validation impact assessments.
• Strong interpersonal and communication skills.
• Strong understanding of applicable regulatory requirements (FDA and EMA).
• Strong understanding of industry standards for commissioning and validation of facilities, utilities and process equipment for cGMP manufacturing.
• Strong understanding of ASTM E2500 CQV lifecycle model.
• Excellent technical writing skills.
• Strong experience in equipment design, installation and start-up.
• Strong experience with performing facility qualification, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification).
• Strong experience with performing utility qualification for the following systems: WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP), CIP, Chilled Glycol, Wastes, etc.
• Strong experience with performing equipment qualification for the following systems: bioreactors, depth filters, mix tanks, autoclaves, chambers, chromatography, tangential flow filtration (TFF), drug product filler/isolator, etc.
• Experience with the qualification of single use technology is desired.
• Experience with the qualification of VHP systems is desired.
• Experience with the qualification of a drug product fill line (including isolator, drug product filler, label, inspection and pack) is desired.