Technical Subject Matter Expert (Suitable for Pharmaceutical/Biological Technical Assistants) | Technischer Fachexperte (m/w/d) - für PTAs/BTAs geeignet
Roche Diagnostics GmbH
Job Summary
This role involves specialized operation and maintenance of complex electronic systems used for compounding and filling sterile solutions into vials and syringes within a pharmaceutical production environment. Key responsibilities include preparing, monitoring, cleaning, and disinfecting filling equipment, performing complex manual interventions via Human-Machine Interfaces (HMI), and executing technical setup tasks of high difficulty during batch changes. The expert will also be heavily involved in digitalization efforts, utilizing systems like Electronic Batch Record, SAP, and Lims for documentation, and participating in qualification and validation activities. The position requires a strong technical background, excellent GMP/hygiene knowledge, and the ability to work in a cleanroom environment (RKL D, C and higher) across a 3-shift operation, ensuring smooth, aseptic filling processes while adhering strictly to manufacturing and regulatory guidelines.
Required Skills
Education
Completed vocational training as a Mechanic, Mechatronics Technician, or Production Technologist (or suitable for Pharmaceutical/Biological Technical Assistants)
Experience
- At least 5 years of professional experience in pharmaceutical production
- Professional experience in machine operation and maintenance of complex electronic systems
- Professional experience with common IT applications (e.g., MS Office programs)
- Experience with qualification and validation activities
Languages
Additional
- Must be willing to work in a 3-shift operation, Must be willing to work on Saturdays
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