Operator with Experience in Calibration

About the job

Background:

Synthetic Molecules Technical Development (PTDC) brings a broad 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) as well as Global Technical Development (PTD).

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

The Plant Support & Compliance team (PTDC-T) is responsible for calibration, infrastructure, operational safety and technical projects in the areas of DS and DP. This is crucial for smooth operations and compliance in the manufacture and development of synthetic molecules. We provide our partners with high-quality service according to cGMP guidelines.

Tasks & Responsibilities:

• Calibration of manufacturing equipment, analytical instruments and monitoring sensors in the areas of Drug Substance (DS) and Logistic Solutions (PS) including their GMP-compliant documentation

• Organisation of calibration activities in coordination with internal partners and external service providers

• Management of test equipment (new acquisition, certification, decommissioning)

• Maintenance of calibration master data using BMRAM / SAP / SAP S4

• Creation/editing of calibration procedures (SOPs)

• Support in handling changes, deviations and Corrective & Preventive Actions (CAPA)

• Expansion of the calibration relief function in the areas of development and commercial

Must Haves:

• You have completed vocational training in a technical or pharmaceutical field (e.g. chemical or pharmaceutical technologist / pharmaceutical operator / chemical operator / automation technician or similar) (****)

• At least three years of experience in a GMP environment (production and/or development). Additional experience/training (preferably in the manufacture of non-sterile active substances) can be an extra advantage (****)

• You possess a strong technical background as well as solid technical understanding of chemical manufacturing equipment and its automation (****)

• You are accustomed to working according to cGMP guidelines (****)

• Ideally, you already have experience with the calibration of measuring devices for chemical manufacturing equipment (****)

• You have very good knowledge of the German language, both spoken and written, as well as solid English skills

• You are independent, proactive and honest, possess high social competence and flexibility, think inclusively and enjoy working in a team with people.

• You work result- and responsibly, question processes for continuous improvement, act customer-focused and make fact-based, consistent decisions

• You are self-motivated, curious, open to the digital world and continuously develop yourself

• You are bold, can represent your position, address uncomfortable topics and encourage opposing views

• SAP experience is an advantage