Kalibriertechniker (m/f/d) - befristet auf 2 Jahre — 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 Synthetic Molecules Technical Development (PTDC) brings a wide range of experience in Drug Substance (DS), Drug Product (DP), Analytical Sciences, Manufacturing Science & Technology and works closely with key partners in research and early development (pRED/gRED) and global engineering (PTD). PTDC is responsible for the technical development of our pipeline, the production of DS and DP for clinical trials, and the commercial production of DS in our manufacturing network. In PTDC, drugs are made from synthetic molecules. We develop robust, cost-efficient manufacturing processes and create knowledge through innovation and continuous improvement in a collaborative environment.

The possibility

The Plant Support & Compliance (PTDC-T) team is responsible for calibration, infrastructure, operational security and technical projects in the areas of DS and DP. This is critical for smooth operation and compliance in the manufacture and development of synthetic molecules. We offer our partners a high-quality service according to cGMP guidelines. As Calibration Technician, you are responsible for the following tasks:

• Calibration of manufacturing plants, analysis devices and monitoring sensors in the areas of Drug Substance (DS) and Logistic Solutions (PS) as well as their GMP-compliant documentation
• Organization of calibration activities in consultation with internal partners and external service providers
• Management of test equipment (re-entry, certification, decommissioning)
• Master data maintenance and system management using SAP S4
• Creation/editing of calibration regulations (SOPs) and quality management by processing changes, deviations and corrective & preventive actions (CAPA)
• Expansion of the calibration jumper function in the areas of development and commercial

Who you are

• You have completed vocational training in the technical or pharmaceutical sector (e.g. chemical or pharmatechnologist/pharmacist/chemical/automatic or similar)
• At least five years of experience in the GMP environment (production and/or development). Further experience/training (preferably in the production of non-sterile active ingredients) can be an additional plus
• They have a strong technical background as well as a solid technical understanding of chemical manufacturing plants and their automation
• You are used to working according to cGMP guidelines
• Ideally, you already have experience with the calibration of measuring instruments of the chemical manufacturing plants
• You have good knowledge of the German and English language in word and writing
• They are independent, proactive and with integrity, have a high level of social competence and flexibility, think inclusively and enjoy working together with people in a team.
• You work in a result- and responsible manner, question processes for continuous improvement, act customer-focused and make fact-based, consistent decisions
• They are self-motivated, curious, open to the digital world and constantly educate themselves. In addition, they courageously move forward, can represent their position, also address unpleasant topics and demand opposing views.

We look forward to your application!

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