CQV Engineer

Lonza • Bend, OR

1d • Onsite

About The Position

The CQV Engineer will partner with engineering, QA, and manufacturing teams to support smooth project execution. This role involves troubleshooting and improving equipment, processes, and systems. The engineer will be responsible for writing, reviewing, and executing qualification protocols (IQ/OQ/PQ) for new and existing equipment, identifying risks to product quality and applying mitigation strategies, and generating validation reports while maintaining compliant documentation following FDA and cGMP guidelines. Additionally, the role includes managing and closing deviations or non-conformances identified during testing and supporting engineering documentation such as user requirements and design qualification materials.

Requirements

• High School Diploma or GED required; engineering degree preferred.
• 3-5 years of experience
• Experience in CQV and temperature mapping.
• Experience in Operational and Performance qualification testing
• 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.

Responsibilities

• 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.

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.
• Relocation assistance is available for eligible candidates and their families, if needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED