QA Engineering Manager, Aseptic Fill-finish Process

**Location**: Stein, AG (Switzerland)

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

Join us as a QA Engineering Manager at Lonza and play a key role in the launch of an aseptic fill-finish line that is part of a major greenfield CAPEX expansion project In this role, you will be responsible for the compliant qualification of an aseptic fill-finish line during the project phases throughout C&Q to the handover to Operations. This role offers a unique opportunity to join the design engineering phase and shape the quality readiness of the line. If you bring experience in aseptic fill-finish processes, we’d love to hear from you

**What you’ll get**:

- An agile career and dynamic working culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance

**What you’ll do**:

- Responsible for ensuring the compliant qualification of an aseptic fill-finish line.
- Ensure that the Direct Impact Systems of the line (e.g. the isolator, vial washer, depyrogenation tunnel, lyo, etc.) are qualified for their intended use according to Lonza's standards and regulatory expectations.
- Manage Quality Risks and compliance gaps to minimize the impact of potential quality issues and ensure regulatory compliance.
- Provide quality oversight on C&Q documents by reviewing and approving them, such as URS, DQ, FAT/SAT, IV, OFT, IQ, OQ, QR, as well as related changes and incidents.
- Support the transition of project phases from the planning and C&Q execution to the handover to Operations and Inspection Readiness.
- Collaborate with the Project Leadership Team to ensure alignment of the project execution strategy and to achieve quality and compliance goals.
- Escalating issues in an open and timely manner and taking leadership for their resolution. Ensure that decisions are fully supported by global and local Quality and Regulatory.

**What we’re looking for**:

- Degree in Mechanical, Engineering, Biotechnology, Pharmacy or related area
- ** Significant experience with aseptic fill-finish processes in a GMP environment is a must**
- Experience in a QA function is a plus
- Strong leadership skills and ability to communicate with various interfaces within the organization and with regulatory agencies (e.g. Swissmedic, FDA)
- Structured, organized, proactive and collaborative working attitude
- Fluency in English is a must, additional skills in German is 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.

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.