CQV Engineer

TL;DR

CQV Engineer (Commissioning, Qualification, and Validation): Supporting the qualification and validation of equipment, processes, and systems for pharmaceutical manufacturing with an accent on IQ/OQ/PQ testing, temperature mapping, and compliant documentation. Focus on identifying quality risks, resolving deviations, and maintaining FDA and cGMP compliance across cross-functional engineering, QA, and manufacturing projects.

Location: Bend, Oregon, USA. Relocation assistance is available for eligible candidates and their families.

Company

A global life sciences organization operating across five continents and manufacturing medicines for customers worldwide.

What you will do

• Partner with engineering, QA, and manufacturing teams to support project execution.
• Troubleshoot and improve equipment, processes, and systems.
• Write, review, and execute IQ/OQ/PQ qualification protocols for new and existing equipment.
• Identify product-quality risks and implement mitigation strategies.
• Prepare validation reports and maintain documentation in line with FDA and cGMP requirements.
• Manage deviations and non-conformances identified during testing, while supporting user requirements and design qualification documentation.

Requirements

• High school diploma or GED required; an engineering degree is preferred.
• 3–5 years of relevant experience in CQV and temperature mapping.
• Experience with operational and performance qualification testing.
• Understanding of FDA, ICH, ISPE, and ISO guidelines.
• Proficiency with Microsoft Word and Excel.
• Strong problem-solving, communication, documentation, and cross-functional collaboration skills.

Culture & Benefits

• Agile career development and a dynamic working culture.
• Inclusive and ethical workplace.
• Performance-based compensation programs.
• Medical, dental, and vision insurance.
• Access to a global benefits program.