Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. As a Member of the Operations Team in a Capital investment project, the Process Expert (PE) provides front line expertise for operational activities within one or more production steps and equipments (AVI, SAVI, MVI & CCIT), with respect to safety, quality and on-time full delivery. Become part of this exciting opportunity and apply now!
Key responsibilities:
- Support of the project team regarding complex topics by use of scientific and statistical knowledge. Incl. Collaboration with the functions in the project and across Drug Product Services, especially the existing DP facilities
- Supports the Head Visual Inspection in developing, prioritizing and achieving goals with respect to the project and overall DPS (Drug Product Services) goal, incl. (but not limited to) qualification, validation and lifecycle management of VI equipments especially SAVI and CCIT.
- Technical improvement execution: Execute improvements, Drive process related trouble shooting/ investigations Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables.
- Provide front line shopfloor support to manufacturing, working with the operator, focusing on manufacturing process and executing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- Deviation, complaint handling: Lead process related investigations and deviations including complaints actions. Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures. Assign, lead and execute actions and CAPAs and changes in Trackwise.
- Support audit: Maintain their processes at Inspection readiness level and to provide the necessary support in any internal or external audit
- Provide training for assigned new processes and products
Key requirements:
- MSc. in Pharmaceutical Technology, Pharmacy, Engineering or equivalent scientific degree / equivalent experience
- First experience in pharmaceutical aseptic production for drug product manufacture especially in automated visual inspection
- Good understanding of visual inspection, vision engineering or image analysis
- Strong understanding of regulations and good manufacturing practices relevant to aseptic manufacture of sterile drug products
- Experienced in ramping up new production facility or new lines
- Solid interpersonal and teamwork skills, able to work cross-functionally and collaborate with various levels
- Flexible, able to respond to daily changing demands
- Effective communicator, verbal and written
- Fluency in German and English
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.
