CQV Engineer

Lonza; Bend (OR); Hybride; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Global benefits program

Career development

Résumé du poste

Lonza in Bend, Oregon is seeking an experienced CQV/qualification engineer to support project execution and validation activities. You will write, review and execute IQ/OQ/PQ for new and existing equipment, identify risks to product quality, and help implement mitigation strategies.

You will generate validation reports and ensure documentation complies with FDA and cGMP guidelines, while collaborating with engineering, QA and manufacturing teams to drive safe, effective drug development.

Qualifications

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

Responsabilités

• 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.

Connaissances

Problem solving

Cross-functional collaboration

Communication

Formation

Engineering degree preferred

Outils

Microsoft Word

Microsoft Excel

Description du poste

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.

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 cross‑functionally.

Strong communication and documentation skills.

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

About Lonza

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.

Reference: R78282

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.