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Cleanroom Control Technician (m/w/d) in Basel Biotech Drug Substance Manufacturing

Roche

Employment type
Full-time
Location
Basel
First posted
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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 The Basel Biologics Drug Substance Manufacturing Organisation is responsible for the production of commercial Biotech-APIs (Active Pharmaceutical Ingredients, e.g. Avastin and Tecentriq) in modern and highly automated facilities. The HVAC & Cleanroom Qualification group is responsible for zone and room qualification concepts, as well as their implementation. It sees itself as a service organization for the Manufacturing Units. The Opportunity Organization, preparation and implementation of various qualification and requalification measurements for zone rooms, cooling and heating rooms (e.g. particle measurements, temperature and humidity measurements, room pressure, recovery time, ....) GMP-compliant documentation and interpretation of measurement arrangements / boundary conditions and measurement results. Collaboration on creating qualification strategies, risk analyses, (re-)qualification plans. Processing of Changes, Deviations, CAPAs, as well as collaboration on the creation of technical assessments for stakeholders. Development and implementation of improvement suggestions for HVAC qualification concepts. Support for teams on qualification issues during authority inspections and in local and global networks, task forces, or project teams. Cooperation with partners from the production and support departments of Basel DS Manufacturing: Partner Units and Value Streams, as well as cooperation with partners from Site Engineering and IT. Work in an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation to achieve business goals. Who You Are You have in-depth experience in the cGMP environment relevant to the pharmaceutical industry. You are also familiar with the operation and qualification / validation of pharmaceutical production facilities and systems. Chemical laboratory assistant or comparable training. Professional experience in the pharmaceutical industry in a production, development or quality function. Experience with room qualifications and temperature mapping is an advantage. Knowledge in the area of HVAC and air distribution systems. Fluent language skills in German and English. You are flexible and willing to work outside of regular working hours in case of an emergency. Please upload your complete application documents. These include your resume, relevant certificates and diplomas (academic and professional) as well as your cover letter, in which you highlight your motivation and suitability for this position. We look forward to your application! Who we are A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advancing science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.

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Posted 6 weeks ago

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