Process Engineer 2

Merck KGaA Darmstadt Germany-posted 3 months ago
$74,500 - $121,700/Yr
Full-time • Entry Level
Madison, WI
Chemical Manufacturing
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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.

  • Develop manufacturing process train for custom products in GMP manufacturing.
  • Support implementation of new manufacturing equipment.
  • Collaborate with Manufacturing, Process Development, and Engineering to determine process needs.
  • Assess facility fit, equipment needs, and manufacturing capabilities for new products.
  • Collaborate with Technical Transfer Scientist on process requirements for GMP transitions.
  • Create detailed process overviews and flow diagrams.
  • Identify and order equipment for GMP manufacturing.
  • Research new equipment and technologies for continuous improvement and capacity expansion.
  • Establish specifications for manufacturing equipment.
  • Generate and approve procedures for equipment qualification and GMP operations.
  • Initiate and review equipment change requests.
  • Support 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).
  • Ability to build a culture of trust and business-driven innovation.
  • 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.
  • Knowledge and understanding 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.
  • Proficient in the use of standard office computers and software for laboratory work.
  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Sales or performance-based bonuses
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