CQV Lead (SGIE) Bio
Today, Lonza is a global leader in life sciences operating across three 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.
The CQV Lead (SGIE - Strategic Growth and Investment Engineering - CAPEX) Bio is responsible for managing and leading teams of engineers and technicians to develop and execute CQV protocols for new equipment, facilities, and processes in compliance with regulatory requirements and quality standards.
Oversee the execution of qualification and validation activities, such as installation, operational, and performance qualification, and ensure that all documentation and reports are accurate and complete.
Manage staffing for projects, identify and lead internal or external resources for appropriate project execution.
Act as subject matter expert (SME) in developing Project Execution Plan and Project Quality Plan and involved committees.
Develop and implement commissioning, qualification, and validation (CQV) strategies aligned with global standards for CAPEX investments portfolio.
Lead CQV activities to ensure compliance with regulatory requirements and industry standards.
Oversee project plans to ensure timely completion of CQV deliverables.
Collaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments.
Provide technical leadership and guidance for CQV activities according to industry standards.
Develop and maintain relationships with key stakeholders for successful project execution.
Conduct training sessions on CQV principles and best practices, identify opportunities for continuous improvement, and implement changes to optimize CQV processes.
Solid experience in Commissioning, Qualification and Validation incl. CSV with good experience in management of pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable
Good leadership skills to drive commissioning and qualification execution strategy in different, complex and dynamic projects.
Flexible individual to manage and adapt to required situations to deliver the project on time and with the right quality to pass the health authorities inspections.
Profound experience in regulated pharmaceutical industry and/or engineering company
Knowledge of ISPE guidelines with proven experience on projects. Proven experience in an EMA / FDA regulated environmental with good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
Language: Very good command of English necessary and knowledge in German desirable
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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.