Responsibilities:
Facility Start-up:
- Provide Process Engineering support to the Global Facility Delivery team for right-first-time and on-schedule start-up (design reviews, process safety assessments, User Requirements, C&Q support, unit operation shakedown and startup, facility operational readiness).
- Define and own relevant aspects of the integrated Operational Readiness Plan (SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, Performance Qualification requirements/protocol development, etc.).
- Own Performance Qualification execution for area of responsibility.
- Develop and implement unit operation and equipment control strategy to sustain and optimize API processes.
- Support initial Operations Training as Equipment/Area SME.
- Lead/support tech transfer of new processes into the facility.
Facility Operations:
- Provide process engineering support in batch API supply or continuous platforms using chemical engineering fundamentals.
- Monitor, assess, and document equipment performance to maintain ongoing qualification.
- Develop and maintain the basis of safety for process equipment.
- Integrate mechanistic modeling, process simulation, and analysis to enhance process understanding and control.
- Identify and implement continuous improvement opportunities (equipment and processes) as part of a cross-functional process team.
- Lead/support tech transfer of new processes and unit operations across batch and continuous platforms.
- Use root cause analysis to investigate issues and deliver corrective and preventative actions.
Basic Qualifications:
- Bachelorβs Degree in Chemical, Biochemical, Pharmaceutical, Biomedical, or Mechanical Engineering.
- 3+ years of relevant manufacturing operations experience (prefer chemical/pharmaceutical).
- Authorized to work in the United States full-time; Lilly does not sponsor work authorization/visas.
Additional Skills/Preferences:
- Strong interest/understanding of Chemical Engineering.
- Experience in ATMP manufacturing.
- Strong analytical and problem-solving skills.
- Ability to work independently and in a diverse process team.
- Creativity to identify improvements and initiative to implement them.
- Ability to guide/mentor others through processes.
- Flexibility to meet business needs.