We are seeking an experienced Process Engineer who will manage a broad range of project activities to successfully scale processes from the bench through pilot plant and into CMOs.
What you'll do:
- Lead internal pilot plant build-out with equipment design and procurement. Lead equipment and utility commissioning/decommissioning and process startup.
- Be responsible for maintaining reliable process equipment performance in one or more manufacturing areas at the pilot/manufacturing facilities including fermentation and utility systems. Resolve daily operational issues in assigned area(s). Work with equipment vendor on equipment maintenance and upgrade. Perform troubleshooting, corrections, and process performance optimization.
- Lead drafting equipment process/sanitization SOP and Preventive Maintenance plans of various process and utility equipment. Conduct training of process team.
- Work closely with our internal Process Development and CMO/CRO partners to deliver an on-target and scalable technology package for product commercialization.
- Support process technology transfer to guarantee accuracy, conformity and competitiveness of the process and techniques utilized.
- Provide input and analysis to process design, establish scale-up/scale-down parameters using engineering fundamentals (mixing, mass transfer, heat transfer, modeling, etc.) and cooperatively work with the teams to develop and optimize process control strategies for fermentation and DSP.
- Support delivering the process technology transfer package and evaluate compatibility of internal and external CMO/CRO facilities with the process requirements. This will include the development of the process design basis, including the sizing, selection and/or retrofit of equipment, mass balance and instrument control.
What we're looking for:
- Bachelor’s degree in Engineering (Chemical Engineering preferred) or Life Sciences with 5+ years experience.
- Prior food GMP experience in a food biotech a plus. Prior experience with production scale biotech process equipment a plus. Prior experience with automation engineering is a plus.
- Good at trouble shooting and problem solving.
- Good oral and written communication skill, and good admin skills.
- Good interpersonal skills.
- In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
- Efficient multi-tasker.
- Full written and verbal fluency in English.
- Some work travel required.
- Domestic and international travel at various times during projects. Travel is intermittent and varies by stage of project.