CQV Engineer

About the Role

This position is located in Bend, Oregon (USA). Relocation assistance is available for eligible candidates and their families, if needed.

What You Will Do

• Partner with engineering, QA, and manufacturing teams to support smooth project execution.
• Troubleshoot and improve equipment, processes, and systems.
• Write, review, and execute qualification protocols (IQ/OQ/PQ) for new and existing equipment.
• Identify risks to product quality and apply mitigation strategies.
• Generate validation reports and maintain compliant documentation following FDA and cGMP guidelines.
• Manage and close deviations or non‑conformances identified during testing.
• Support engineering documentation such as user requirements and design qualification materials.

Requirements

• High School Diploma or GED required; engineering degree preferred.
• Experience in CQV and temperature mapping.
• Understanding of FDA, ICH, ISPE, and ISO guidelines.
• Proficiency with Microsoft Word and Excel.
• Ability to solve problems and work cross‑functionally.
• Strong communication and documentation skills.
• Interest in improving systems and supporting safe, effective drug development.

Benefits

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Medical, dental, and vision insurance.
• Access to Lonza's global benefits program.