Manufacturing Support Associate

Job summary
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOJoin FDB and help manufacture the next vaccine, cure or gene therapyWe are growing our locations, capabilities, and teams and looking for passionate mission-driven people
Job seniority: mid-to-senior level
Responsibilities
• Lead operational readiness initiatives and site commissioning and qualification efforts• Troubleshoot for respective process area• Perform documentation updates• Coordinate non-batch activities and create associated documentation• Create change management records, investigations, CAPAs, and CI activities• Execute and drive general improvement projects within Drug substance manufacturing• Organize equipment startup and transfer into GMP manufacturing• Support inspections and audits by providing requested manufacturing documents• Perform other duties as assigned
Requirements
• 6 years of related experience with a High School Diploma or GED• Associate's or BA/BS degree• 2 years of direct experience with a BA/BS Degree• 4 years of direct experience with an Associate's Degree• Military experience or equivalence
Key Skills Needed
• Strong knowledge of manufacturing operations and troubleshooting• Experience in coordinating manufacturing support activities• Proficiency in Change Management, Supporting Investigations, CAPAs, and CIs