Calibration Expert

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 manufacture of DS and DP for clinical trials as well as for the commercial manufacture of DS in our manufacturing network. In PTDC, synthetic molecules are turned into medicines. We develop robust, cost-efficient manufacturing processes and create knowledge through innovation and continuous improvement in a collaborative environment.

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 crucial for smooth operations as well as compliance in the manufacture and development of synthetic molecules. In doing so, we offer our partners a high-quality service according to cGMP guidelines.

The perfect candidate: The ideal candidate has completed technical or pharmaceutical vocational training as well as at least three years of experience in a GMP environment and a sound understanding of chemical manufacturing plants including automation; additional knowledge in the manufacture of non-sterile active ingredients and in the calibration of measuring instruments represents an advantage. Very good German and English skills as well as ideally SAP experience round off the profile.

Personally, this specialist impresses through initiative, integrity and teamwork, works independently as well as result- and responsibility-oriented, questions processes for continuous improvement and makes fact-based decisions. At the same time, they show a brave, curious mindset with openness to digital developments and the ability to address demanding topics clearly.

Tasks & Responsibilities:

• Calibration of manufacturing plants, 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 backup function in the areas of Development and Commercial

Must Haves:

• You have completed vocational training in the technical or pharmaceutical field (chemical or pharmaceutical technologist/ pharmaceutical technician/ chemical technician/ automation technician or similar) ()
• Min. three years of experience in a GMP environment (production and/or development). Further experiences/training (preferably in the manufacture of non-sterile active ingredients) can 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 used to working according to cGMP guidelines ()
• Ideally, you already have experience with the calibration of measuring instruments of the chemical manufacturing plants ()
• You possess very good knowledge of the German language in speaking and writing as well as solid English skills
• You are independent, proactive and integral, possess high social competence and flexibility, think inclusively and enjoy working in a team with people.
• You work result- and responsibility-oriented, question processes for continuous improvement, act customer-focused and make fact-based, consistent decisions
• You are self-motivated, curious, are open to the digital world and continuously educate yourself
• You move forward bravely, can represent your position, also bring up unpleasant topics and demand opposing views
• SAP experience is an advantage

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