Senior Principal Process Engineer will be responsible to provide process development and engineering support for process automation, technology development, tech transfers, process validation and GMP manufacturing with Class III medical device experience to work on delivery. Primary responsibility will be to engage in automation and technology development activities within the company and facility.
- Perform development and implementation of new process technology
- Perform process design and process simulation studies to support process automation projects
- Perform laboratory process development studies, data analysis, and author technical reports
- Write and review technical documentation (development reports, batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing).
- Perform process monitoring, process capability, statistical analysis and quality engineering activities
- Support technology transfer and oversee GMP manufacturing operations; serve as person-in-plant
- Lead or participate on a cross-functional development team or a tech transfer team
- Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies
- Perform hands-on activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters
- Operationalize new technology or product transfer to ensure successful manufacturing in clinical or commercial plants
- Lead or participate in process improvements across various product development phases
- Bachelor’s or Master’s Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 7+ years of experience.
- Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices
- Aseptic processing experience
- Class II and III med device experience a must
- Experience performing process design and process automation is a plus
- Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus