Description
The Production Engineer is a key technical role within INCOG BioPharma Engineering and Technical Operations to ensure data integrity, implement state-of-the-art digital technologies, process control strategies, and support the technology road map. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling, sterile manufacturing, and engineering principles.
This Engineer will operate during 3rd shift, typically holding hours Sunday-Thursday from 11:00PM-7:30AM.
Essential Job Functions:
Resolve issues that arise per daily operation and provide timely responses and solutions
Implement solutions in collaboration with cross-functional technical teams and site leadership
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
Minimum Education and Experience:
Bachelor's degree in engineering field or life sciences with 5+ years of relevant work experience
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development
Hands-on experience troubleshooting, repairing and performing preventative maintenance of manufacturing equipment
Additional Preferences:
Lean Six Sigma Certification
Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
Applicable experience with process design, data integrity, controls, instrumentation, and electro-mechanical systems
