Mitarbeiter Kalibrierung / Technical Writer (m/w/d) im Bereich Plant Support & Compliance

About

«Synthetic Molecules Technical Development? (PTDC) brings a broad range of experience in Drug Substance (DS), Drug Product (DP), Analytical Sciences, Manufacturing Science & Technology, working closely with key partners in Research and Early Development (pRED / gRED) and Global Technical Development (PTD). PTDC is responsible for the technical development of our pipeline, the manufacturing of DS and DP for clinical studies, and the commercial manufacturing of DS in our manufacturing network. In PTDC, synthetic molecules become medicines. We develop robust, cost-effective 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 DS and DP areas. The role is crucial for the smooth operation and compliance in the manufacturing and development of synthetic molecules. We offer our partners high-quality service in accordance with cGMP guidelines.

The perfect candidate (m/f/d) has completed vocational training in a technical or pharmaceutical field (e.g., chemical or pharmaceutical technologist, pharmaceutical/chemical technician, or automation technician) and has at least five years of experience in a GMP environment, ideally also with Synthetic Molecules experience. The person has a strong technical understanding of chemical-pharmaceutical plants and their automation, is experienced in calibrating measuring instruments, and works safely according to cGMP guidelines. Furthermore, the person masters German and English, both spoken and written.

Work Schedule

Standard, 40h/week

Responsibilities

• Performing calibrations on manufacturing equipment, analytical instruments, and monitoring sensors for Drug Substance (DS) and Logistic Solutions (PS), and documenting them in compliance with GMP.
• Creating/processing deviations, including root cause analysis.
• Creating/processing Corrective & Preventive Actions (CAPA).
• Creating/processing changes.
• Creating/processing calibration documents (SOPs).
• Managing test equipment (new entries, certification, decommissioning).
• Maintaining calibration master data using BMRAM / SAP / SAP S4.
• Coordinating calibration activities in consultation with internal partners.
• Organizing external services.
• Expanding the calibration support function in the DS and DP areas.

Qualifications

• Completed vocational training in a technical or pharmaceutical field (e.g., chemical or pharmaceutical technologist/pharmaceutical/chemical technician/automation technician or similar).
• Minimum of five years of experience in a GMP environment (production and/or development).
• Additional experience/training (preferably within Synthetic Molecules) can be an added advantage.
• Strong technical background and solid understanding of chemical/pharmaceutical plants and their automation.
• Accustomed to working according to cGMP guidelines.
• Experience in calibrating measuring instruments for chemical/pharmaceutical manufacturing plants.
• Good knowledge of German and English, both spoken and written.
• A positive-thinking, independent, proactive, and integrous personality with high social competence and flexibility.
• Open to the digital world and willing to expand skills in digital systems.
• Results-oriented, taking responsibility for work and interested in continuously questioning and improving even seemingly established processes.
• Self-motivated, curious, and continuously expanding skills through lifelong learning.
• Inclusive mindset, enjoys working in a team, and enjoys interacting with people.
• Courageous, able to assert their position, willing to address difficult topics, and solicit opposing views.
• Strong customer focus, makes fact-based decisions, and executes them accordingly.

Application

Are you interested? Then Mr. André Amstad looks forward to receiving your complete application documents (CV, certificates, and training records). We look forward to hearing from you.

Please apply by email to amstad@we-make-it.ch

We look forward to hearing from you.