Engineer - Reliability

Eli Lilly Eli Lilly · Pharma · US: Research Triangle Park, NC

Reliability Engineer responsible for establishing and executing maintenance and reliability strategies to ensure equipment and process uptime in a regulated healthcare manufacturing environment. This role involves data analysis of key metrics (MTTR, MTBF, OEE), root cause analysis of failures, implementing reliability improvements, and supporting cross-functional teams. Experience with vision systems, CMMS, and regulatory compliance (cGMP, FDA) is preferred.

What you'd actually do

  1. Plays a key role in establishing maintenance and reliability strategy for the department.
  2. The position will support Reliability Engineering initiatives across various departments at RTP.
  3. This is a hands-on role where the engineer may be required to perform troubleshooting of equipment, root cause analysis, component and system analyses to identify reliability improvements and reduce risks, recommend/execute design modifications and/or various reliability improvement strategies.
  4. Lead all initiatives for equipment/ process uptime – including data collection, analysis, coordinating with x-functional team, identifying parts, parameter changes, etc, all the way thru implementing the change (with appropriate documentation and approvals).
  5. Utilize appropriate techniques and tools (RCA, RCM analysis, failure analysis, etc.) to investigate and reduce equipment-related deviations and downtime.

Skills

Required

  • Bachelor’s degree in engineering or related technical field
  • 6 years’ experience in a regulated industry
  • Troubleshoot equipment or process problems
  • Prepare necessary training material and conduct training
  • Promote proper use of the CMMS system and ALCOA+ principles

Nice to have

  • Experience in using and directing the use of FMEA and RCA processes.
  • Demonstrated ability to work independently without close supervision.
  • Adequate interpersonal and communications skills to be able to work effectively in a team-based environment.
  • Strong computer skills in a variety of software packages (Microsoft Office, etc.).
  • Ability to work in a safe manner to ensure the safety of self and others.
  • Knowledge of automation systems/software to facilitate data collection
  • Working knowledge of vision systems (Cognex, Keyence) to create, modify, edit tools, etc.
  • Working knowledge of FDA Regulations including cGMP.
  • Working knowledge of ISO standards, IEC standards and industry best practices.
  • Working knowledge of Preventive and Predictive Maintenance techniques, including but not limited to Tribology, Vibration Analysis, Thermography, Life Cycle Cost Analysis, equipment installation requirements, etc.
  • Experience/working knowledge of compressors, air handling units (AHUs’), aseptic processing operations, water of injection (WFI) production, clean steam generation
  • Ability to make individual, small group and large group presentations.
  • Must be able to lead, interact with and coach wide variety of individuals: shop floor mechanics to senior operations and maintenance management.
  • Ability to make and communicate verbally and in writing, logical decisions using data.
  • Experience using IBM-Maximo software application or other CMMS system
  • Certified Maintenance & Reliability Professional (CMRP) and/or Certified Reliability Engineer (CRE) Certification

What the JD emphasized

  • 6 years’ experience in a regulated industry
  • Working knowledge of FDA Regulations including cGMP
  • Working knowledge of ISO standards, IEC standards and industry best practices