Senior Associate - Manufacturing Engineering
Elanco
August 12, 2026
On-site
Fort Dodge, IA
Operations
Your Role: Lead Commissioning, Qualification & Validation (CQV) Engineer
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.
Minimum Qualifications:
- Bachelor’s degree in engineering.
- Minimum 3 years of CQV experience within the life sciences, pharmaceutical, biotechnology, or manufacturing industry.
- Strong knowledge of GMP regulations, equipment commissioning, qualification and validation, with proven leadership and project management abilities.
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.
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.
Minimum Qualifications:
- Bachelor’s degree in engineering.
- Minimum 3 years of CQV experience within the life sciences, pharmaceutical, biotechnology, or manufacturing industry.
- Strong knowledge of GMP regulations, equipment commissioning, qualification and validation, with proven leadership and project management abilities.
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.