CQV Engineer: Pharma Validation & IQ/OQ/PQ

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

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.