CQV Engineer

Bend, OR

The actual location of this job is 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 non013conformances identified during testing.

• Support engineering documentation such as user requirements and design qualification materials.

What we are looking for:

• 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 cross013functionally.

• Strong communication and documentation skills.

• Interest in improving systems and supporting safe, effective drug development.