Senior Associate - Manufacturing Engineering

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.

Requirements

• 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.

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.