Sr. Process Engineer

Key Responsibilities

• Monitor equipment and process performance using defined indicators to proactively identify risks to production and opportunities for optimization.
• Provide engineering and equipment input for technical transfer of new processes from development into the manufacturing area.
• Identify, lead, and implement continuous improvement initiatives related to equipment performance, reliability, and process capability.
• Maintain a comprehensive working knowledge of manufacturing processes, associated equipment, facilities, computer systems, and operational practices.
• Drive completion of assigned projects by leading multi-disciplinary teams to develop scope, agree to design, and efficiently execute project goals.
• Serve as the primary resource for safety issues associated with supported processes and equipment.
• Conduct equipment investigations and lead implementation of corrective and preventative actions.
• Ensure equipment remains in a qualified state through appropriate monitoring, maintenance, and documentation.
• Serve as the primary point of contact for introduction of new consumables or changes to existing consumables.
• Lead or support equipment commissioning and qualification activities for new and existing assets.
• Act as the user representative for capital projects, providing operational and technical input throughout design, construction, and startup.
• Develop and deliver training materials and tools to transfer equipment knowledge to operations and maintenance teams.
• Support development, review, and approval of preventive maintenance procedures and spare part strategies.
• Ensure ongoing compliance with applicable Health, Safety, and Environment (HSE) and Quality requirements.

• B.S. in engineering (Chemical Engineering, Biomedical Engineering, or Mechanical Engineering preferred)
• 3+ years’ experience in a manufacturing environment supporting GMP operations

• Experience with Change Management, Deviation Management, Commissioning and Qualification, and/or Routine Data Monitoring
• Root cause analysis experience
• Pharmaceutical experience
• Familiarity with industrial computer systems (e.g., UNICORN, Delta
  
  V, OSI PI)

• Monday through Friday, 8-hour days with flexibility for occasional off-hours support
• Travel: 0%–10%