Project Change and CAPA Lead

Elanco • Winslow, ME

13d

About The Position

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Your Role: 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.

Requirements

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

Nice To Haves

• 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).

Responsibilities

• 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/preventative 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level