Cleanroom Control Expert E&T Kaiseraugst (80-100%) — Roche

Full description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position At Roche, 94,000 people in over 100 countries are working on the future of healthcare. Together we became one of the leading research pharmaceutical companies. Our success is based on innovation, curiosity and diversity.

With its 1400 employees, the Kaiseraugst Production Center (PTM) ensures uninterrupted patient care with high-quality drugs. PTM stands for the highest standards of pharmaceutical manufacturing, Roche’s largest, most innovative packaging centre and the supply of more than 120 countries.

The E&S (Engineering & SHE) support function supports production with its technical expertise and ensures the regulatory requirements for our products throughout the entire life cycle. For a successful production site in Kaiseraugst, we are driving progress through scientific and technical competence and forward-looking service. We achieve this by continuously improving our processes, agile employees and passion.

Due to our interface function, numerous contacts in the entire production area are available for you.

The possibility

As a “Cleanroom Control Expert”, you are mainly responsible for supporting the area of EMT trend analyses and the hygiene area, by advancing relevant projects (e.g. harmonisation of growing concepts, etc.) up to supporting day-to-day business through trend analyses.

• Projects for the optimisation/harmonisation of behavioural concepts in clean rooms and gowning concepts
• Conducting trend analyses of EMT monitoring data (viable/non-viable monitoring) incl. Advancing CAPAs in the event of anomalies
• Ensuring timely monitoring and trending activities in compliance with all GMP specifications and processes
• Troubleshooting, carrying out root cause analyses, preparation of technical impact assessments
• Preparation/revision of standard operating procedures (SOPs) and associated GMP documents and risk analysis
• Optimization of processes as well as support for the implementation of new processes and systems including documentation and ownership of the associated technical changes
• Ensuring a good flow of information
• Preparation, monitoring and follow-up of official inspections and audits
• Willingness to work in a self-organized team with a high degree of personal responsibility in an open and collaborative environment
• Close cooperation with production, internal and external interfaces to achieve ambitious throughput, quality, commitment and cost goals
• Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety

Who are you

You are a positive thinking, integrity and self-reflecting personality with strong team skills. With this in mind, you bring an open and collaborative attitude and mindset that is needed for successful work in your team and across departments. You trust yourself and others, take responsibility and live an open speak-up and error culture.

Your solution-oriented attitude and can-do attitude determines your daily actions.

You have a degree in a natural/engineering degree program or relevant professional experience. Professional experience in pharmaceutical production or a close industry of at least