Responsibilities :
- Resolve issues that arise in day to day running of operation and providing timely responses and solutions
- Implement solutions in collaboration with cross-functional technical teams and site leadership team
- SME for filling equipment and supporting systems
- Evaluate and improve efficiency of manufacturing instruments, equipment, and tools
- Evaluate and implement new changes
- Participate and / or support process FMEAs to understand process and product risks as a pre-requisite for process validation.
- Provide technical support to manufacturing activities
- Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
- Partner with vendors and suppliers to define requirements and understand functional specifications
- Work flexible hours to ensure production facility coverage
Qualifications :
- Bachelor’s degree in engineering field, or life sciences with 5+ years of relevant work experience
- Or 10+ years of relevant work experience
- Lean Six Sigma Certification
- Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development
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