Senior Associate - Manufacturing Engineering

Elanco in; Fort Dodge (IA); On-site; USD 100,000 - 140,000; Full time

Job summary

Elanco seeks a Senior Associate - Manufacturing Engineering (CQV) to lead the Commissioning, Qualification, and Validation program at the Fort Dodge site. You will provide technical leadership to ensure equipment and systems are Commissioned, Qualified, and Validated in GMP alignment while driving improvements across the site.

You will collaborate with Engineering, Quality, and cross-functional teams to standardize processes, manage external resources, and uphold a strong safety culture in a

Qualifications

• Minimum of 3 years of Commissioning, Qualification and Validation (CQV) experience in life sciences, pharma, biotech, or manufacturing.
• Strong knowledge of GMP regulations, equipment commissioning, qualification and validation; proven leadership and project management abilities.

Responsibilities

• Lead CQV program for the Fort Dodge site, ensuring compliance with Elanco standards and regulatory requirements.
• Develop, maintain, and improve CQV processes, including SOPs, templates, and qualification documentation.
• Provide technical oversight for equipment commissioning, qualification, validation, and related engineering projects.
• Drive continuous improvement through Lean principles and cross-functional collaboration.
• Promote safety culture by evaluating equipment and systems for risk and ensuring compliant operations.

Skills

GMP regulations

CQV experience

Project management

Leadership

Job description

Senior Associate - Manufacturing Engineering (Project Management)

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)

• 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.