Senior Associate - Manufacturing Engineering

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 include:

• Leading the site-wide Commissioning, Qualification, and Validation (CQV) program, ensuring compliance with Elanco standards and regulatory requirements.
• Developing, maintaining, and improving CQV business processes, including ownership of SOPs, templates, and qualification documentation.
• Providing technical guidance and oversight for equipment commissioning, qualification, validation, and engineering projects while managing internal and external CQV resources.
• Driving continuous improvement through Lean principles, process optimization, and collaboration with Engineering, Quality Assurance, and cross-functional teams.
• Championing a strong safety culture by evaluating equipment and systems for potential safety risks and ensuring safe, compliant operations.

To succeed in this role, you need:

• 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:

• 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.

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