CQV Engineer

Lonza; Bend (OR); On-site; Confidential; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Lonza’s global benefits program

Job summary

Lonza in Bend, Oregon is seeking a hands-on CQV/qualification focused engineer to support project execution and ensure compliant validation activities.

You will write, review and execute IQ/OQ/PQ protocols, mitigate risks to product quality and maintain GMP documentation in alignment with FDA, ICH, ISPE and ISO guidelines.

The role requires collaboration with engineering, QA and manufacturing, plus strong problem-solving and cross-functional communication.

Qualifications

• 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.

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.

Skills

CQV

Temperature mapping

Problem solving

Cross-functional collaboration

Documentation

Communication

FDA guidelines

ICH guidelines

ISPE guidelines

ISO guidelines

Microsoft Word

Microsoft Excel

Education

High School Diploma or GED

Engineering degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

The actual location of this job is in Bend, Oregon (USA). Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

What you will get:

• 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.

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.

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 cross‑functionally.
• Strong communication and documentation skills.
• Interest in improving systems and supporting safe, effective drug development.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.