Sterile Manufacturing Specialist

Lonza is a global leader in life sciences, operating across three continents. While we work in science, there's no one-size-fits-all approach to achieving success. Our greatest scientific solution is talented individuals working together to devise innovative ideas that help businesses impact people's lives positively.

We are seeking an experienced Sterile Manufacturing Specialist - Process Optimization to join our team. As a key member of our manufacturing organization, you will be responsible for the successful implementation and transfer of Drug Product processes in our new sterile facility in Stein. Your expertise will also contribute to capital investment projects, process development, and Contamination Control Strategy.

• Process Implementation and Transfer: Oversee the successful transfer of information, process-related risks, and change control during technology transfer.
• GMP Risk Analysis: Participate in risk analysis for manufacturing processes and develop strategies to mitigate potential issues.
• Qualification and Validation: Prepare and perform qualification and validation activities in compliance with cGMP regulations and specification requirements.
• Change Controls and Deviations: Lead or participate in change controls and deviations, ensuring timely resolution and minimal disruption to operations.
• Continuous Improvement: Identify opportunities for process performance improvement and product quality enhancement.

To succeed in this role, you will need:

• At least 5-10 years of experience in Sterile Manufacturing on the shopfloor and/or MSAT, QC/QA.
• Visionary communication skills and ability to interact effectively with diverse stakeholders within customers and project organizations.

Lonza offers a dynamic work environment that values innovation, collaboration, and growth. If you're passionate about advancing life sciences and improving people's lives, we encourage you to apply.