Utilities Process Engineer

Eli Lilly Eli Lilly · Pharma · Pleasant Prairie, WI

The Utilities Process Engineer will be a Subject Matter Expert (SME) for HVAC and Utilities systems (GMP and non-GMP) in a pharmaceutical manufacturing facility. Responsibilities include ensuring systems are in alignment with industry and company standards, supporting risk assessments, monitoring utility systems, providing technical assistance, troubleshooting equipment failures, and ensuring compliance with Health, Safety, and Environmental policies. The role requires a Bachelor's degree in Engineering or related field, technical understanding of HVAC and Utilities, knowledge of cGMP, and proficiency with relevant software and systems like TrackWise and CAPA.

What you'd actually do

  1. Be the SME with a deep technical expertise in all systems under scoped responsibility (GMP and non-GMP HVAC, GMP and non-GMP Utilities and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, understanding flow charts and process parameters, and awareness of industry trends.
  2. Ensure the assigned processes are in alignment with Industry and Lilly Standards.
  3. Support risk assessment exercises using the different tools available (e.g., FMEA).
  4. Monitor utility systems and maintain KPI’s to assure that they are operating properly, in compliance with requirements.
  5. Apply problem solving skills by leading equipment failures troubleshooting, demonstrating RCA lead investigator proficiency, and guide operations personnel in the resolution of process issues.

Skills

Required

  • Bachelor of Science – Engineering or field related to project management/engineering, or equivalent experience.
  • Technical understanding of HVAC and Utilities.
  • Demonstrated office software skills (Word, Excel, Power Point, Outlook, UMS, data historian) and collaboration sites.
  • Knowledge of cGMP.
  • Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards.

Nice to have

  • Previous start up experience.
  • Engineering experience in the pharmaceutical industry.
  • Previous equipment commissioning experience.
  • Engineering experience with manufacturing plant utilities.
  • Project management experience.
  • Experience with maintenance and computerized maintenance management systems (CMMS).
  • Previous experience with deviation and change management systems including TrackWise.
  • ME, EE, or Chem E would be beneficial.

What the JD emphasized

  • cGMP
  • Health, Safety, and Environmental policies
  • Process Safety Management