Principal Process Engineer

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your role:

 

The Principal Process Engineer is responsible for developing the manufacturing process train for custom products in GMP manufacturing and bringing in new manufacturing equipment. This role works cross-functionally with Manufacturing, Process and Analytical Development, Engineering, Validation, and customers to determine process needs and requirements for transferring production processes into the GMP space.

 

• Assesses facility fit, equipment needs, and manufacturing capabilities for potential new products.
• Determines process needs/requirements for processes moving from Development to GMP.
• Creates detailed process overviews and flow diagrams.
• Identifies and assists in ordering equipment for use in GMP manufacturing.
• Establishes manufacturing equipment specifications.
• Generates, reviews, and approves engineering, manufacturing, and quality procedures necessary to support equipment qualification and operation of equipment in GMP manufacturing (procedures and product-specific recipes).
• Initiates, reviews/approves equipment change requests.
• Develops and/or implements systems improvement projects and supports Maintenance and Manufacturing groups in resolving technical and engineering issues.
• Supports Manufacturing and Maintenance groups in troubleshooting manufacturing equipment.
• Supports Validation in Equipment and Process Validation activities per GMP regulations.
• Facilitates training for individuals involved in the operation and maintenance of processes and equipment introduced to the manufacturing department.
• Act as liaison between manufacturing and site engineering.
• Perform impact and risk assessments for processes and unit operations for evaluation or regulatory support.
• Own manufacturing FMEA for evaluation of critical processing characteristics.
• Consult with global marketing on design of new sellable items related to ADC manufacturing.
• Design complex equipment fit for purpose for bioconjugation facilities.
• Design and implement studies to support robust understanding of equipment/process (mixing uniformity, agitation and flow rates, heat transfer, shear etc).
• Consult with GMP Maintenance & Engineering for feasibility evaluations of large scale equipment.
• Provide process engineering support facility design based on processing needs.
• Subject matter expert for all production processes.
• Identify new equipment and technologies to support continuous improvement, efficiency, and capacity expansion of core capabilities.
• Support/own manufacturing facility CAPEX as needed.
• Consult for project design of new build or expansion projects on compatibility with manufacturing process.
• Support GMP Maintenance & Engineering by defining process requirements for utilities/equipment.
• Support GMP Maintenance & Engineering to define process utility capacity relative to manufacturing process capabilities.