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.
Main Responsibilities:
- 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.
Candidate Requirements:
- 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 aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference 54345 in all correspondence.
