Manufacturing Senior Associate 12 hour PM shift
On-siteNew Albany, Ohio, United States
Job Summary
Manage and lead all aspects of a device assembly and packaging line, maintaining full cGMP compliance while overseeing production equipment to ensure schedules are met. Perform equipment setup, operation, and troubleshooting to maintain machine uptime, including fault clearing and stoppage resolution on automated systems. Provide training to manufacturing staff and offer technical support for process and equipment issues on the floor. Collaborate with Quality, Engineering, and Manufacturing Support to resolve manufacturing events, manage Deviation Triage, and lead Corrective and Preventive Actions. Write, review, and revise controlled documentation including SOPs and manufacturing procedures. Champion Lean Transformation and operational excellence initiatives while participating in process equipment commissioning, qualification, and validation.
Required Qualifications
- High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
- Associate's + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
- Bachelor's + 6 months biotech or pharmaceutical manufacturing, process development or quality experience
- Master's Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering or Life Sciences
Desired Qualifications
- Technical understanding of pharmaceutical/biotech packaging equipment and processes
- Experience with Current Good Manufacturing Practices (cGMP)
- Ability to be flexible and manage change
- Experience participating in and leading cross-functional teams
- Experience in managing multiple, competing priorities in a fast-paced environment
- Strong scientific, technical interactions with partner organizations such as PD and F&E
- Experience in GMP Tech Support roles, GMP operations, process development or scheduling
- Experience with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification
- Ability to organize, analyze, and interpret technical data that is impacting operations
- Background in lean manufacturing methodologies and operational excellence
- Expertise in electronic systems used in manufacturing (MES, LIMS, Maximo, CCMS, SAP, etc.)
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