Project and CAPA Lead

Process Change & CAPA Lead

As the Process Change & CAPA Lead, you will be part of a dedicated process team to deliver end-to-end lifecycle management of change controls and Corrective and Preventive Actions (CAPAs). In this role, you’ll be responsible for providing technical leadership for process and equipment modifications while ensuring full regulatory compliance and operational efficiency.

• Serve as the primary owner for the initiation, technical leadership, and timely completion of all change controls, CAPAs, and Master Production Record (MPR) updates.
• Lead process deviations and quality events by performing robust root cause analysis and implementing effective corrective/preventive actions to prevent recurrence.
• Drive continuous improvement by identifying cost-effective process enhancements and participating in the Site Value Office committee.
• Collaborate cross-functionally with Operations, Engineering, HSE, and Quality Assurance to ensure alignment on project goals and safety standards.
• Act as a technical liaison for external contractors and vendors while ensuring on-floor practices match documented quality standards.

• Education:
  
  Bachelor's Degree in a relevant field or equivalent level of experience.
• Experience:
  
  A minimum of 4-6 years of relevant experience in change management, quality systems, or process support within a manufacturing environment.
• Top 2 skills:
  Project management (including design, construction, and qualification) and excellent technical communication/SOP writing.

• Knowledge of the principles and guidelines of CFR 9 and the USDA.
• Experience using Veeva Systems for quality and document management.
• Preferred experience with process support in a regulated industry (e.g., FDA, USDA, EMA).
• Expertise in Statistics and Statistical Process Control (SPC) capability.
• Demonstrated leadership capabilities and experience in Lean Manufacturing techniques (e.g., Six Sigma).

Elanco is an EEO/Affirmative Action Employer and does 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.