Sr. Process Engineer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

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* Key Responsibilities:

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* + 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.

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* Minimum Requirements:

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* + 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_

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** 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%

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