Process Engineer

Process Engineer GMP Operations CapEx 

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 260 operating companies in more than 60 countries employing approximately 135,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 350 people of over 20 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products and therapies.

Essential

• Living local to Bern
• Immediately available (1 or 2 weeks maximum notice)
• Speak German & English

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 non conformities.
   
• 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/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 infrastructure
• 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
• 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 2021 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!