Project Change and CAPA Lead

Posted 25 Days Ago
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Winslow, ME, USA
In-Office
Mid level
Healthtech • Pharmaceutical • Manufacturing
The Role
The Project Change and CAPA Lead is responsible for managing change controls and CAPAs, driving process improvements, and ensuring regulatory compliance in manufacturing.
Summary Generated by Built In

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.

Your 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 You Need to Succeed (minimum qualifications):
  • 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.
What will give you a competitive edge (preferred qualifications):
  • 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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Skills Required

  • Bachelor's Degree in a relevant field or equivalent level of experience
  • 4-6 years of relevant experience in change management, quality systems, or process support within a manufacturing environment
  • Project management skills
  • Excellent technical communication/SOP writing

Elanco Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elanco and has not been reviewed or approved by Elanco.

  • Leave & Time Off Breadth Time off options are broad, including PTO, flexible leave, and the ability to purchase additional vacation. These provisions are highlighted as supportive of work-life balance.
  • Healthcare Strength Health coverage includes medical, dental, and vision alongside company-paid life, disability, and wellness support. Pet insurance and assistance programs reinforce a comprehensive wellbeing offering.
  • Retirement Support Retirement offerings include a U.S. 401(k) and, for some employees, access to a defined benefit pension. These programs add meaningful long-term value to total rewards.

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The Company
HQ: Greenfield, Indianna
8,445 Employees

What We Do

At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives. Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society. Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco

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