QA Critical Utilities Lead

Vor 3 Tagen

Stein, Schweiz Lonza Vollzeit

Switzerland, SteinToday, 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.

In order to support the strategic investments of the company, the Quality SGIE Team (Strategic Growth Investment & Engineering) is looking for an experienced quality leader responsible for the GMP compliance of critical utilities in our growth CAPEX projects portfolio in Stein, Switzerland.

Key responsibilities:

- Responsible for the GMP compliance of critical utilities (i.e. clean water, clean steam, compressed gases, clean rooms, and HVAC) during the project management lifecycle from design to qualification and handover.
- Provide quality oversight on CQV documents as well as related change controls and deviation management.
- Provide leadership and guidance to staff on qualification/validation issues.
- Ensure that decisions are fully supported by global and local Quality and Regulatory
- Escalating issues in an open and timely manner and taking leadership for their resolution

Key requirements:

- Bachelor or Master's degree in Mechanical, Engineering, Biotechnology, Pharmacy or any other relevant areas
- Several years of experience in Engineering with the main focus on GMP critical utilities i.e. clean water, clean steam, compressed gases, clean rooms, and HVAC
- Significant experience in the GMP regulated pharmaceutical industry, preferably with a Project Quality Lead role
- Strong leadership skills and ability to communicate with all kinds of interfaces within the organization and with regulatory agencies (Swissmedic, FDA, etc.)
- Structured, organized, proactive and collaborative working attitude
- Strong verbal and written communication skills
- Fluent in English, German would be an advantage

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.

**Reference: R46384**:

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