Production Engineer

Responsibilities

• Resolve day to day operational issues and provide timely responses and solutions.
• Implement solutions in collaboration with cross-functional technical teams and site leadership.
• Serve as SME for prep and formulation equipment and supporting systems.
• Evaluate and improve efficiency of manufacturing instruments, equipment, and tools.
• Evaluate and implement new changes.
• Support process FMEAs to understand process and product risks ahead of validation.
• Provide technical support to manufacturing activities.
• Apply Good Engineering Practices (GEP) to drive engineering and operational excellence.
• Partner with vendors and suppliers to define requirements and functional specifications.
• Work flexible hours to ensure production facility coverage.

Essential Qualifications

• Bachelor's degree in an engineering field or life sciences with 5+ years of relevant work experience.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing support (prep and formulation), and process development.
• Hands-on experience troubleshooting, repairing, and performing preventative maintenance of manufacturing equipment.