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 nonconformances 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.

• 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 crossfunctionally.

• Strong communication and documentation skills.

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

Ready to shape the future of life sciences? Apply now.