The Lead Commissioning, Qualification & Validation (CQV) Engineer at Elanco will be part of the Engineering team, focusing on leading the CQV program for the Fort Dodge manufacturing site. This role involves providing technical leadership to ensure compliance with GMP requirements while promoting continuous improvement and operational excellence. The engineer will work closely with dynamic individuals and cross-functional teams to enhance processes and safety culture. This position is crucial for ensuring that manufacturing equipment and systems are effectively commissioned, qualified, and validated.

• Bachelor's degree in engineering.
• Minimum of 3 years of Commissioning, Qualification, and Validation (CQV) experience within the life sciences, pharmaceutical, biotechnology, or manufacturing industry.
• Strong knowledge of GMP regulations, equipment commissioning, qualification and validation.
• Proven leadership and project management abilities.

• 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.

• Employees at Elanco are often offered competitive compensation with annual bonus and equity eligibility, retirement plans (including a U.S. 401(k)), and comprehensive health coverage—medical, dental, vision, company-paid life and disability—and even pet insurance. Time-off and flexibility typically include generous PTO, U.S. mid-year and year-end paid shutdown weeks, parental leave, and flexible/remote work options. Employees also benefit from strong development programs (onboarding, course libraries, mentorship, nine ERGs, and tiered leadership programs) that support both professional growth and community involvement.