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Process Engineer GMP Operations CAPEX- 4991 ETH
Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Supply Network Planner on contract basis until December 2022 with an option of extension based in central Switzerland.
- Provide engineering and technical support for complex production and process equipment (50L) for GMP Operations
- Develop process excellence techniques to identify systematic issues. Track trends and implement equipment and/or process enhancements that will improve efficiency, product yield, and equipment reliability.
- Lead in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process nonconformities.
- Review evaluations and advice on the selection of suitable equipment for optimized, balanced line performance and makes final recommendations to management.
- Provide technical leadership of cross functional teams (Technical Services/QA/C&Q) on installation & qualification of new equipment within GMP Operations
- Perform complex technical work including the design, manufacture and operation of equipment and systems.
- Initiate changes in agreement with GMP Operations in order to improve the current production on different aspects (e.g. cost-wise, time-wise or with handling)
- Support GMP Operations on SAP tasks in order to update equipment repair histories, provide technical data updates, and input necessary changes to equipment bill of materials.
- Support the creation, processing, and closing of Quality Issues related to GMP production. Support the creation/update of SOPs, WIs and other relevant documents according to GDP.
- Support GMP Operations in various emergency situations during production such as ordering materials, label creation and coordination with other departments such as QA, QC or WH
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Pharmaceutical/Biotechnological/Life Science background and ideally an advanced training/Master/Ph.D degree in engineering
- Practical experience in technical support of biotechnological manufacturing facilities including aseptic manufacturing areas and infrastructures
- Knowledge of GMP-requirements and their technical implementation in cleanrooms and health, work & safety and environment requirements are an advantage
- Experience in project management, theoretical or practical
- Fluency in English, decency in German
- Good PC-skills, enjoy working with IT-Systems (SAP, Trackwise, eLIMS)
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