Production Engineer

Job Responsibilities:

• Resolve issues that arise in day to day running of operation and provide 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 the 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
• 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