Sr. Process Engineer
Eli Lilly and Company
2 months ago
On-site
Indianapolis, IN
Operations
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.
Minimum Requirements
- B.S. in engineering (Chemical Engineering, Biomedical Engineering, or Mechanical Engineering preferred)
- 3+ years’ experience in a manufacturing environment supporting GMP operations
Additional Skills and Preferences
- 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, DeltaV, OSI PI)
Additional Information
- Monday through Friday, 8-hour days with flexibility for occasional off-hours support
- Travel: 0%–10%
- 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.
Minimum Requirements
- B.S. in engineering (Chemical Engineering, Biomedical Engineering, or Mechanical Engineering preferred)
- 3+ years’ experience in a manufacturing environment supporting GMP operations
Additional Skills and Preferences
- 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, DeltaV, OSI PI)
Additional Information
- Monday through Friday, 8-hour days with flexibility for occasional off-hours support
- Travel: 0%–10%