DescriptionThe 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 is a weekend shift with hours from Friday-Sunday from 7:00PM-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
