Operator with experience in calibration

Background:

Synthetic Molecules Technical Development? (PTDC) brings a wide range of experience in the areas of Drug Substance (DS), Drug Product (DP), Analytical Sciences, Manufacturing Science & Technology and works closely with important partners in the areas of research and early development (pRED / gRED) as well as global technical development (PTD).

PTDC is responsible for the technical development of our pipeline, the manufacturing of DS and DP for clinical trials as well as for the commercial manufacturing of DS in our manufacturing network. In PTDC, medicines are made from synthetic molecules. We develop robust, cost-efficient manufacturing processes and create knowledge through innovation and continuous improvement in an environment of collaboration.

The Plant Support & Compliance (PTDC-T) team is responsible for calibration, infrastructure, operational safety and technical projects in the areas of DS and DP. This is of crucial importance for smooth operation as well as compliance in the manufacturing and development of synthetic molecules. In doing so, we offer our partners a high-quality service according to cGMP guidelines.

Tasks & Responsibilities:

• Calibration of manufacturing equipment, analytical 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 testing equipment (new registration, certification, decommissioning)
• Maintenance of calibration master data using BMRAM / SAP / SAP S4
• Creation/processing of calibration instructions (SOPs)
• Support in the processing of Changes, Deviations and Corrective & Preventive Actions (CAPA)
• Expansion of the calibration standby function in the areas of Development and Commercial

Must Haves:

• You have completed vocational training in a technical or pharmaceutical field (chemistry or pharmaceutical technologist/ pharmaceutical technician/ chemical technician/ automation technician or similar) ()
• At least three years of experience in a GMP environment (production and/or development). Further experiences/training (preferably in the manufacture of non-sterile active ingredients) may represent an additional plus point ()
• You possess a strong technical background as well as a solid technical understanding of chemical manufacturing plants and their automation ()
• You are accustomed to working according to cGMP guidelines ()
• Ideally, you already have experience with the calibration of measuring devices of chemical manufacturing plants ()
• You possess very good knowledge of the German language in spoken and written form as well as solid English skills
• You are independent, proactive and upright, possess high social competence and flexibility, think inclusively and enjoy working in a team with people.
• You work in a result-oriented and responsible manner, question processes for continuous improvement, act in a customer-focused manner and make fact-based, consistent decisions
• You are self-motivated, curious, open to the digital world and continuously further your education
• You move forward courageously, can represent your position, also bring up unpleasant topics and demand opposing views
• SAP experience is an advantage

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