QA Engineering Manager, Aseptic Fill-Finish Process

QA Engineering Manager, Aseptic Fill-Finish Process

Lonza

Stein, Switzerland

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 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.