Biology, Commissioning, Communication Skills, Compensation and Benefits, Conformance Testing, Cross-Functional, Current Good Manufacturing Practice (cGMP), Dental Insurance, Documentation, Drug Development, Equal Employment Opportunity (EEO), FDA (Food and Drug Administration), High School Diploma, ICH Regulations, ISO (International Organization for Standardization), Identify Issues, Manufacturing, Medical Products, Microsoft Excel, Microsoft Word, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Validation, Product Support, Project Execution, Regulatory Compliance, Reporting Skills, Risk Analysis, Safety Standards, Validation Documentation, Vision Plan, Writing Skills
Biopharmaceutical Validation And Commissioning Specialist
The actual location of this job is in Bend, Oregon (USA). Relocation assistance is available for eligible candidates and their families, if needed.
This role offers an exciting opportunity to support validation and commissioning activities in a regulated biopharmaceutical environment. You will play a key role in ensuring equipment, systems, and processes meet quality and compliance standards that enable the delivery of life-changing therapies.
This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.
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
- Opportunities for professional growth and development
- Exposure to cross-functional teams and impactful projects
What You Will Do
- Partner with engineering, quality, and manufacturing teams to support project execution
- Troubleshoot and improve equipment, processes, and systems
- Write, review, and execute qualification protocols, including IQ, OQ, and PQ
- Identify risks to product quality and support mitigation strategies
- Generate validation reports and maintain compliant documentation
- Manage and close deviations or non-conformances during testing activities
- Support development of engineering and validation documentation
What We Are Looking For
- High school diploma or GED required; degree in engineering or related field preferred
- Experience in commissioning, qualification, and validation or similar environments
- Knowledge of FDA, cGMP, and industry guidelines such as ICH, ISPE, or ISO
- Proficiency with Microsoft Word and Excel
- Strong problem-solving skills and ability to work across teams
- Clear written and verbal communication 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.
Ready To Shape The Future Of Life Sciences? Apply Now.