Process Engineer GMP Operations CapEx // Johnson & Johnson

Job content

Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 140,000 people.

Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 600 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.

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
• 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 process and system owners on design and characterization of new innovative equipment and processes and follow their implementation towards a GMP environment
• Provide technical expertise across a broad range of engineering areas
• 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
  

Who We Are Looking For

• Pharmaceutical / Biotechnological / Life Science background and ideally an advanced training / Master / PhD 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
• Good PC-skills, enjoy working with IT-Systems (SAP, Trackwise, eLIMS)
• Proactive, open-minded, problem solving and team-oriented personality with strong communication skills
• An attraction for multitasking, prioritizing, and organizing in order to accomplish the assigned projects in an autonomous manner and also in coordination with other internal or external stakeholders is required

This job in our CapEx/CAR-T project team is based in Bern, Switzerland and will initially be limited until December 2022 with the opportunity to be extended long term. If you are interested in working for a global leading health care company, in a highly dynamic and flexible work environment, then send us your application today. Or give us a call if you have any questions!

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