Principal Process Engineer - Manufacturing Sciences & Technology, Upstream

Principal Process Engineer - Manufacturing Sciences & Technology

This role provides on-call and on-the-floor technical support to manufacturing. The position involves drafting and reviewing documentation, compiling and assessing process data, and providing technical input for investigations and change controls. It is client-facing and requires strong collaboration with clients and internal teams to move projects forward.

Shift: Monday – Friday, core hours 8am-5pm

Location:

Madison, WI 100% Onsite

• Develop and execute technical work plans and schedules independently, ensuring projects stay within scope and meet performance standards.
• Author and approve technical documents such as protocols, technology transfer reports, operating procedures, and batch production records.
• Review technical documents for accuracy, completeness, and regulatory compliance.
• Train, coach, and mentor others on technical and business topics. Motivate, coach, and develop coworkers as a subject matter expert
• Participate in client meetings, provide technical support, and lead projects across multiple disciplines.
• Support development of business strategies and new technologies for multiple customers across company sites.
• Collaborate with cross-functional teams to transfer and maintain processes in the facility.
• Work closely with manufacturing to author batch documentation and provide technical oversight for GMP manufacturing.
• Compile process data, communicate project status, identify trends, and deliver presentations.
• Evaluate existing processes and recommend improvements to enhance efficiency and consistency. Support building business cases for process improvement projects.
• Author and review documents including batch records, tech transfer reports, and engineering specifications.
• Lead technical support for risk assessments, gap analysis, deviations, change controls, and CAPAs.
• Oversee technical support of manufacturing, including technology transfer between external clients or process development and manufacturing.
• Collaborate with engineers and scientists to drive facility fit and technical transfer of mammalian biologic processes. Evaluate, align, and recommend equipment and process improvements.
• Support technology transfer of processes into manufacturing for both internal and external processes.

• Bachelor's degree in a STEM discipline and more than 15 years of related experience, OR Master's degree in a STEM discipline and more than 12 years of related experience, OR Doctorate degree in a STEM discipline and more than 8 years of related experience.
• 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.
• Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with Environmental Health and Safety responsibilities.

• Commercial or large-scale cell culture experience and equipment troubleshooting.
• Experience working on late-phase, process performance…