Process Engineer 2

Merck-posted 2 days ago
Full-time • Mid Level
Madison, WI
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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 process engineer is responsible for developing the manufacturing process train for custom products in GMP manufacturing and supporting the implementation of new manufacturing equipment. This role will collaborate with Manufacturing, Process Development, and Engineering to determine process needs and requirements for transferring production processes into the GMP space. Assesses facility fit, equipment needs, and manufacturing capabilities for new products. Collaborates with the Technical Transfer Scientist on process requirements for GMP transitions. Creates detailed process overviews and flow diagrams. Identifies and orders equipment for GMP manufacturing. Research new equipment and technologies for continuous improvement and capacity expansion. Establishes specifications for manufacturing equipment. Generates and approves procedures for equipment qualification and GMP operations. Initiates and reviews equipment change requests. Supports troubleshooting, systems improvement projects, and training for manufacturing equipment operation.

  • Developing the manufacturing process train for custom products in GMP manufacturing and supporting the implementation of new manufacturing equipment.
  • Collaborating with Manufacturing, Process Development, and Engineering to determine process needs and requirements for transferring production processes into the GMP space.
  • Assessing facility fit, equipment needs, and manufacturing capabilities for new products.
  • Collaborating with the Technical Transfer Scientist on process requirements for GMP transitions.
  • Creating detailed process overviews and flow diagrams.
  • Identifying and ordering equipment for GMP manufacturing.
  • Researching new equipment and technologies for continuous improvement and capacity expansion.
  • Establishing specifications for manufacturing equipment.
  • Generating and approving procedures for equipment qualification and GMP operations.
  • Initiating and reviewing equipment change requests.
  • Supporting troubleshooting, systems improvement projects, and training for manufacturing equipment operation.
  • Bachelor’s in Chemical and Mechanical Engineering, Chemistry, Biochemistry, or related Life Science discipline.
  • 5+ years’ experience in GMP Operations or a related field.
  • Comprehensive technical knowledge and understanding of GMP manufacturing equipment.
  • Excellent attention to detail and the ability to effectively manage multiple projects.
  • Effective communication and engagement skills (verbal, written, listening) with the ability to work with internal departments and customers.
  • Ability to build a culture of trust and business-driven innovation; work with internal organizations to solve ongoing issues within the team.
  • Ability to communicate and lend guidance on day-to-day workflow and overcoming challenges related to completing projects.
  • Experience in API manufacturing.
  • Experience in production with fixed equipment of 200 L or larger.
  • Experience in handling High-Potency APIs is a plus.
  • Experience with scaling processes from gram quantities to multi-kilogram quantities.
  • Strong scientific problem-solving skills, including the ability to identify critical issues in experimental work and suggest possible solutions.
  • Knowledge and understanding of the overall goals, implementation, and application of cGMP and other relevant quality systems.
  • Superior organizational skills and the ability to multi-task proficiently.
  • Excellent communication skills, including the ability to give presentations and speak to large groups, as well as establish rapport with non-technical parts of the company.
  • Proficient in the use of standard office computers and software for laboratory work (data capture, data analysis, etc.) and statistical analysis, specifically MS Office 365, MS Project, ChemOffice, etc.
  • health insurance
  • paid time off (PTO)
  • retirement contributions
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