Senior Associate - Manufacturing Engineering
On-siteFort Dodge, Iowa, United States
Job Summary
Lead the site-wide Commissioning, Qualification, and Validation (CQV) program for the Fort Dodge manufacturing site, 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.
Required Qualifications
- 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
- Project management abilities
Desired 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
- Validation lifecycle principles
- Excellent communication skills with the ability to influence technical and non-technical stakeholders while driving project execution
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