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Sr. Process Engineer

Lead technology transfers and optimize equipment performance for API manufacturing during clinical trials
Indianapolis, Indiana, United States
Mid-Level
$66,000 – 171,600 USD / year
yesterday
Eli Lilly

Eli Lilly

Develops and manufactures innovative pharmaceutical therapies for diabetes, oncology, immunology, neuroscience, and other serious chronic diseases worldwide.

Engineering Role In Process Engineering Group

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

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 or Mechanical Engineering preferred)
  • 3+ years of experience working in a manufacturing environment supporting GMP operations

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)

Monday through Friday 8 hour days with flexibility to provide occasional off hours support. Travel: 0% - 10%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).

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.

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Sr. Process Engineer
Indianapolis, Indiana, United States
$66,000 – 171,600 USD / year
Engineering
About Eli Lilly
Develops and manufactures innovative pharmaceutical therapies for diabetes, oncology, immunology, neuroscience, and other serious chronic diseases worldwide.