Principal Process Engineer - Manufacturing Sciences & Technology, Upstream
On-siteMadison, Wisconsin, United States
Job Summary
Develop and execute technical work plans independently, authoring and approving protocols, technology transfer reports, and batch production records. Compile process data to identify trends, lead risk assessments, and drive corrective and preventive actions for deviations. Provide on-call and on-the-floor technical support for GMP manufacturing, collaborating with cross-functional teams to transfer processes and optimize equipment. Mentor staff and deliver presentations to clients while evaluating existing processes to recommend efficiency improvements. Monday through Friday core hours with occasional on-call rotation required for this 100% onsite role in Madison, WI.
Required Qualifications
- Bachelor's degree in a STEM discipline
- Master's degree in a STEM discipline
- Doctorate degree in a STEM discipline
- More than 15 years of related experience (for Bachelor's degree holders)
- More than 12 years of related experience (for Master's degree holders)
- More than 8 years of related experience (for Doctorate degree holders)
- Experience in report and documentation skills
- Experience with statistical techniques for data analysis and reporting
- Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally
- Experience in investigating and closing deviations, out-of-specification results, and corrective and preventive actions
- Experience drafting and revising standard operating procedures, batch production records, and reports
- Experience with operating and troubleshooting process equipment, including single-use systems and consumables
- Subject matter expertise in upstream (mammalian cell culture) or downstream (e.g., depth filtration, chromatography, tangential flow filtration, viral filtration, bulk drug substance fill) manufacturing processes across current Good Manufacturing Practice biologics production scales
- Experience in facility fit, process scaling, and technology transfer
- Ability to see, hear, read, and write clear English
- Must comply with Environmental Health and Safety responsibilities
- Frequent lifting and/or moving up to 10 pounds
- Occasional lifting and/or moving up to 50 pounds
Desired Qualifications
- Commercial or large-scale cell culture experience and equipment troubleshooting
- Experience working on late-phase, process performance qualification, and commercial programs
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.