Senior Associate - Manufacturing Engineering

Posted 23 Days Ago
Be an Early Applicant
Fort Dodge, IA, USA
In-Office
Senior level
Healthtech • Pharmaceutical • Manufacturing
The Role
Lead the site-wide Commissioning, Qualification, and Validation (CQV) program for a manufacturing site, ensuring GMP-compliant equipment commissioning, qualification and validation. Develop and maintain CQV processes, SOPs and documentation, provide technical leadership to internal and external teams, drive Lean continuous improvement, and ensure safety and regulatory compliance across projects.
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: Lead Commissioning, Qualification & Validation (CQV) Engineer

As the Lead CQV Engineer, you will be part of the Engineering team responsible for leading the Commissioning, Qualification, and Validation (CQV) program for the Fort Dodge manufacturing site. In this role, you will provide technical leadership to ensure manufacturing equipment and systems are commissioned, qualified, and validated in compliance with GMP requirements while driving continuous improvement, standardization, and operational excellence across the site.

Your Responsibilities
  • Lead the site-wide Commissioning, Qualification, and Validation (CQV) program, ensuring compliance with Elanco standards and regulatory requirements.
  • Develop, maintain, and improve CQV business processes, including ownership of SOPs, templates, and qualification documentation.
  • Provide technical guidance and oversight for equipment commissioning, qualification, validation, and engineering projects while managing internal and external CQV resources.
  • Drive continuous improvement through Lean principles, process optimization, and collaboration with Engineering, Quality Assurance, and cross-functional teams.
  • Champion a strong safety culture by evaluating equipment and systems for potential safety risks and ensuring safe, compliant operations.
What You Need to Succeed (minimum qualifications)
  • Education: Bachelor's degree in engineering.
  • Experience: Minimum of 3 years of Commissioning, Qualification, and Validation (CQV) experience within the life sciences, pharmaceutical, biotechnology, or manufacturing industry.
  • Top 2 skills: Strong knowledge of GMP regulations, equipment commissioning, qualification and validation, combined with proven leadership and project management abilities.
What Will Give You a Competitive Edge (preferred qualifications)
  • Experience leading CQV programs for pharmaceutical, biologics, or vaccine manufacturing facilities.
  • Demonstrated success managing external contractors and cross-functional project teams.
  • Experience implementing Lean manufacturing and continuous improvement initiatives.
  • Strong understanding of regulatory compliance, risk management, and validation lifecycle principles.
  • Excellent communication skills with the ability to influence technical and non-technical stakeholders while driving project execution.

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 engineering
  • Minimum 3 years CQV (Commissioning, Qualification, Validation) experience in life sciences, pharmaceutical, biotechnology, or manufacturing
  • Strong knowledge of GMP regulations
  • Experience with equipment commissioning, qualification and validation
  • Proven leadership and project management abilities
  • Experience leading CQV programs for pharmaceutical, biologics, or vaccine manufacturing facilities
  • Experience managing external contractors and cross-functional project teams
  • Experience implementing Lean manufacturing and continuous improvement initiatives
  • Strong understanding of regulatory compliance, risk management, and validation lifecycle principles
  • Excellent communication skills with ability to influence technical and non-technical stakeholders

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: Indianapolis, IN
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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