CQV Engineer
Lonza · Bend, OR · 3 mo ago
EngineeringFull-time
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.