Your Role: Lead Commissioning, Qualification & Validation (CQV) EngineerAs 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.
