CSV / CQV Validation Specialist

Join our Commissioning, Qualification, and Validation (CQV) team in Bend, OR to play a vital role in executing critical validation lifecycles that keep life-saving manufacturing and laboratory operations running smoothly.

This is a 6–9 month full-time contract role based entirely on-site in Bend, Oregon. On-site presence is essential to support hands-on instrument qualification, physical field execution, and cross-functional alignment across campus facilities.

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Opportunity to work with industry-standard digital validation platforms (Kneat).

• Competitive contract hourly rate.

• Validation Lifecycle Execution: Develop, execute, review, and close validation deliverables, including URS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, deviations, and summary reports.

• Dual Team Support: Split priorities between CQV priorities and the Instrumentation team's Computer Systems Validation (CSV) requirements for analytical laboratory instruments and GxP equipment.

• Data Integrity & Compliance: Ensure calibration readiness, system retirement documentation, and strict adherence to 21 CFR Part 11, EU Annex 11, Annex 15, and USP/ASTM standards.

• Digital Validation Platform: Create, route, and manage validation workflows using the Kneat validation software platform.

• Cross-Functional Collaboration: Partner with Quality Control, Engineering, Quality Assurance, and Automation to manage change controls, impact assessments, CAPAs, and inspection-ready documentation.

• Education: Bachelor’s Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.

• Experience: Minimum 3–5 years of CQV and/or CSV experience within the pharmaceutical, biotechnology, or regulated GxP industry.

• Laboratory Focus: Proven hands-on experience qualifying analytical laboratory instruments and computerized systems. Previous backlog remediation experience is highly desirable.

• Technical Software Skills: Demonstrated proficiency using Kneat validation software for document creation and digital workflow approval.

• Regulatory Expertise: In-depth knowledge of cGMP, 21 CFR Part 11, 21 CFR Parts 210/211, Annex 11/15, and data integrity requirements.

• On-Site Capability: Ability to work full-time on-site in Bend, OR, travel between campus buildings, wear required lab PPE, and occasionally lift up to 50 lbs.

Founded in 1897 in the Swiss Alps, our business has embraced innovation and kept pace with a fast-changing world for more than 125 years.

We are the CDMO that opened the door to a new era of medicine – one where breakthroughs could be produced at scale and made available around the world. Our contributions have led the way in drug approvals in our industry.

The therapies we help bring to life reach up to 100 million people each year, and we contribute to around one in every ten medicines that are newly approved by the FDA.

Political, regulatory, or economic disruption in one region doesn’t put the brakes on our business as our global network of 30+ sites across five continents provides resilience against global instability.

We are a community of big thinkers and bold doers. We focus on what matters, and together we make it happen. We are constantly pushing ourselves to make things better, never stopping until we make it right.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, protected veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

At Lonza, we are committed to building an inclusive workplace where diverse perspectives are valued and respected. We believe that diversity strengthens our teams, drives innovation, and helps us better serve our employees, customers, and communities. Reasonable accommodations are available for qualified individuals with disabilities throughout the recruitment process.