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Senior Process Engineer

1 month ago

Durham, North Carolina, United States Lilly Full time
Job Summary

We are seeking a highly skilled Senior Process Engineer to join our team at Lilly. As a key member of our Parenteral manufacturing area, you will be responsible for supporting the asset delivery, process development, commissioning, qualification, validation, and startup of associated processes and equipment.

Key Responsibilities
  • Lead the areas of equipment prep, formulation, and filling, and become the lead SME in the area.
  • Develop and implement process strategies, partnering with other areas to develop and implement validation strategies.
  • Provide technical support for root cause investigations related to process equipment.
  • Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
  • Prepare technical documents, such as change controls, commissioning and qualification test cases, and process changes.
  • Work within cross-functional teams to implement Process Engineering objectives.
  • Collaborate with partners across the Parenteral Network and teams to ensure harmonization across platform.
  • Build and drive safety and quality culture within the organization.
  • Provide technical support in terms of SOP approvals, verification and design documents reviews and approvals, and on-field support as required.
  • Ensure equipment is properly maintained in a qualified state for reliable supply of medicine.
Requirements
  • Bachelor's degree in Engineering.
  • Previous equipment qualification and process validation experience.
  • Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, and OSHA.
  • Prior experience with regulatory and internal audits.
  • Previous experience with highly automated equipment.
  • Previous facility or area start-up experience.
  • Previous experience with Manufacturing Execution Systems and electronic batch release.
  • Ability to work 8-hour days - Monday through Friday.
  • Ability to work overtime as required.
About Lilly

Lilly is a global healthcare leader committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs.

We are an EEO/Affirmative Action Employer and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups offer strong support networks for their members and help our company develop talented individuals for future leadership roles.