This position is an engineering role within the Process Engineering group in the Bioprocess Clinical Trials Manufacturing Facility, supporting the manufacture of bulk drug substance (API). Individuals in this role provide engineering support to the maintenance and operations teams as needed to maintain production of API for development and clinical trial purposes. This role serves as a key interface between development and operations during technology transfer activities and acts as the primary contact for equipment troubleshooting and performance issues.
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 the 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 implementation of project goals.
- Serve as the primary resource for safety issues associated with supported processes and equipment.
- Conduct equipment related investigations and lead implementation of associated corrective and preventative actions.
- Ensure equipment remains in a qualified state throughout its lifecycle through appropriate monitoring, maintenance, and documentation.
- Serve as the primary point of contact for the 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 and operational practices to operations and maintenance teams.
- Support the development, review, and approval of preventive maintenance procedures and spare part strategies.
- Ensure ongoing compliance with all applicable Health Safety and Environmental (HSE) and Quality requirements.
Minimum Requirements:- Bachelors of science degree in engineering (Chemical Engineering, Biomedical Engineering, or Mechanical Engineering preferred)
- 3+ years of experience working in a manufacturing environment supporting GMP operations
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Additional Skills and Preferences: - Previous experience with Change Management, Deviation Management, Commissioning and Qualification and/or Routine Data Monitoring
- Experience using root cause analysis techniques for the systemic solving of problems.
- Pharmaceutical experience
- Familiarity with industrial computer systems (e.x. UNICORN, DeltaV, OSI PI)
Additional Information:- Monday through Friday 8 hour days with flexibility to provide occasional off hours support.
- Travel: 0% - 10%
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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