Process Engineer GMP Operations CapEx
QLS are recruiting for a Process Engineer GMP/CAPEX to join a project with a Global Pharmaceutical Company based in Bern on a contract basis until the end of the year but likely to be extended as the company runs contract every calendar year. They doproject review every end of the year.
- Provide engineering and technical support for complex production and process equipment for GMP Operations (? 50L process equipment).
- 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.
- Owner of allocated ETS record with low to medium impacts
- 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 process and system owners on design and characterization of new innovative equipment and processes and follow their implementation towards a GMP environment.
- 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/update of SOPs, WIs and other relevant documents according to GDP.
- Support GMPOperations in various emergency situations during production such as ordering materials, label creation and coordination with other departments such as QA, QC or WH.
- Pharmaceutical/Biotechnological/Life Science background and ideally an advanced training/Master/Ph.D degree in Engineering.
- Previous work experience in a similar function.
- 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 required, German is also required at a decent level; additional languages are a plus.
- Good PC-skills, enjoy working with IT-Systems (SAP, Trackwise, eLIMS).
- Proactive, open-minded, problem solving and team-oriented personality with strong communication skills.
The position offers a great opportunity with a dynamic, technically demanding and highly regulated environment and the possibility to contribute to important project for the growth and development of the company.
Apply: For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email email@example.com. Please could you send any correspondence in English. Please quote reference 54345 in all correspondence.