process engineer drug product operations (w/m/d) // johnson & johnson à Bern

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 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines in Bern (Switzerland) 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 300 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. We are committed to bringing meaningful innovation to global health by combating major threats to the health of people worldwide.

Main Responsibilities

• Implementation of Drug Product suspension filling under GxP for the production of vaccines and other products
• Support document readiness for suspension filling in the Fill & Finish production unit in the Pilot Facility
• Plan and perform process support activities (buffer preparation/ equipment preparation, autoclaving/waste removal)
• Establish, review and Implementation of process related procedures (Batch Records/ Standard operation procedures, Reports,...)
• Evaluate product/process performance and deviations, trouble shooting, performance of change activities, tracking and reporting key production and quality indicators against established metrics
• Propose new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance
• Administrate preparation of engineering specifications and documentation for manufacturing equipment; communication with external parties for purchasing of and commissioning of new equipment
• Support Qualification and Validation activities related to F&F processes, equipment/ rooms
• Take over assigned projects within the F&F area

Who we are looking for

• Bachelor or Master Degree within the area of Biotechnology, Food Technology, Biology or similar
• Work experience in a pharmaceutical company is a plus
• In depth knowledge of aseptic processing
• Flexible team player with the ability to prioritize
• Ability to work according to tight and changing timelines
• Accurate working and documentation style
• Open and flexible for other temporary assignments according to business needs
• Basic Knowledge of Regulatory Principles
• Good documentation practice
• Flexibility on working hours (late-/night shift 1x per week)
• Analytical thinking and problem-solving ability
• Enhanced Communication ability
• Fluent German
• Flexibility on working hours (late-/night shift 1x per week)

This job based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!