Technical Associate (m/f/d) – Plant Qualification/ Plant Design / GMP / Production / Plant Validation/ SAP/ VEEVA / Interface Communication / German
Project:
For our client, a large pharmaceutical company based in Basel, we are looking for a Technical Associate (m/f/d)
Background:
The Department of Pharmaceutical Development is responsible for the development of parenteral drugs from phase 1 to market launch. Activities include the development of formulation and manufacturing processes for parenteral drug products for all clinical phases and the market, the transfer of products and processes to commercial production sites, commercial product support, and the development of line extensions.
The perfect candidate has either completed technical vocational training with at least 5 years of practical work experience in a manufacturing, Gx P-regulated company or a degree in the technical or scientific field. Professional experience in the field of plant qualification, plant design or production support as well as in the qualification or validation of plants and equipment is an advantage. The position requires very good communication skills in German and English.
Main tasks and areas of responsibility:
Tasks & responsibilities:

• Maintenance/calibration/servicing of all small and large systems in pharmaceutical development (pilot plant and laboratories)- scheduling of maintenance with the plant manufacturers / certification bodies- On-site support of maintenance personnel- Documentation of maintenance in maintenance software- Archiving of all existing and new systems Documents in the archive- Coordination of repairs with the Local engineering / workshop - troubleshooting / adaptation of plants to new processes- supervision of the monitoring of the TCS / sterile rooms- support of the entire equipment lifecycle of all "qualified plants"- CAPEX - support for the procurement of new process plants- orders of services / materials in the context of process plants
• Ensuring the "compliance" of the plants and laboratory equipment in pharmaceutical development with applicable verification SOP- Re-verification of new plants- Inventory in local systems- Equipment change control
• Employee instruction / training on new systems / in case of modification of existing plants Troubleshooting Scheduling, shutdown of analytical equipment and manufacturing plants

Must haves:

• Either completed vocational training in the field of laboratory technology, mechatronics or comparable with at least 5 years of practical work experience in a manufacturing, Gx P regulated company Or completed studies in the technical or scientific field (chemistry, biochemistry, biotechnology, etc.) Professional experience in the field of plant qualification, plant design or production support is an advantage Professional experience in qualification or validation of systems and equipment is an advantage Experience with SAP, VEEVA is an advantage Fluent knowledge of German and English is required Very good communication skills and ability to work in a team Experience in interface communication is an advantage, especially with internal customers and external service providers

Reference No.: 923655SDA
Role: Technical Associate (m/f/d)
Industry: Pharma
Place of work: Basel (Home office: max. 20%)
Workload : 90-100%
Start: ASAP (Latest possible start date: 01.02.2025)
Duration: Unlimited
Application deadline: 24.09.2024
Job Type: 90-100%
Work Location: On the road
Application Deadline: 21/09/2024