Senior CQV Engineer — GMP Biopharma Validation Leader

US29 Lonza Bend Inc.; Bend (OR); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

401(k) with match

Relocation assistance

Bonus program

Job summary

Lonza in Bend, Oregon is seeking a Senior CQV Engineer to lead commissioning, qualification, and validation activities for biopharma manufacturing equipment.

You will partner with operations, facilities, and quality to design and qualify processes, troubleshoot systems, and drive continuous improvement while ensuring GMP compliance. This in-person, site-based role emphasizes collaboration, technical excellence, and delivering safe, reliable production.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• 5+ years of engineering in a regulated manufacturing environment.
• Experience in biotechnology, pharmaceutical, or life sciences industries.
• Knowledge of GMP requirements and validation principles.
• Strong technical, analytical, and problem-solving skills.

Responsibilities

• Lead engineering activities supporting research, operations, facilities, and capital projects.
• Troubleshoot equipment and systems while driving continuous improvements.
• Design, improve, commission, and qualify manufacturing equipment and processes.
• Prepare and review engineering documentation, protocols, reports, and SOPs.
• Support change controls, validation activities, and GMP compliance.
• Partner with cross-functional teams to assess risks and improve system reliability.
• Support manufacturing operations to ensure safe, reliable, and efficient production.

Skills

Engineering experience

GMP knowledge

Analytical skills

Communication skills

Mentoring others

Education

Bachelor's degree in Engineering

Job description

Lonza in Bend, Oregon is seeking a Senior CQV Engineer to lead commissioning, qualification, and validation activities for biopharma manufacturing equipment.

You will partner with operations, facilities, and quality to design and qualify processes, troubleshoot systems, and drive continuous improvement while ensuring GMP compliance. This in-person, site-based role emphasizes collaboration, technical excellence, and delivering safe, reliable production.