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
Lonza Pharma & Biotech has an excellent opportunity for a Manager, CQV Engineering to join their Product Development team at their Bend, Oregon location.
Key Responsibilities:
- Move projects in the readiness stage from commissioning to IOQ approval and handed off to operations.
- Managing in-house/contracted project teams of commissioning, qualification, and validation engineers and start-up specialists to meet organization’s CQV/Compliance requirements.
- In addition to CQV deliverables, support the development of RACI matrices to help all teams understand roles and responsibilities.
- Work in close conjunction with the process engineering team and provide status updates to project PMs.
- Ensure seamless transfer from OQ handoff to operations/MSAT with a focus on production ramp up rates and equipment optimization.
- Define and standardize on CQV best practices and processes that support full GMP readiness.
- Supports and promotes an openness for change and new ideas, cooperative teamwork and continuous improvement even outside the CQV area of responsibility
- Onboarding of contractor teams through Lonza job codes
- Lead check-in meetings with contractor leadership teams
- Prepare and execute change controls and validation protocols for new and existing GMP equipment
- Ability to communicate internally and externally at higher levels; strong business understanding
- Outsource external CAPA support as necessary to support process engineering team deliverables
- Support/consult with EMF teams during manufacturing emergencies and compliance remediations
Key Requirements:
- B.S./B.A. degree in engineering preferred or equivalent education and experience
- Minimum 5 years of experience in biotech, pharmaceutical or medical device manufacturing and process equipment is preferred
- 3-5 years experience performing Commissioning, Qualification and Validation activities and/or leading CQV projects and providing direction to external CQV individuals and teams
- Experience leading projects and providing direction for contractor teams
- Experience as a people manager preferred
- Strong leadership, writing, and communication/presentation skills are required
- Demonstrated balance of collaborative leadership and autonomous problem solving
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
