25 Jun, 2021

Process Engineer

  • Johnson & Johnson
  • Berne, Switzerland
Process Engineer Biochemicals / Pharmaceuticals Chemicals

Job Description

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 AG, 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.

 

Main Responsibilities

  • Execution of the practical project work within a cGMP regulated environment. To a process engineer an implicit lead function in process execution can be assigned.
  • Carry out core Fill and Finish processes (formulation of final bulk, manual and automated aseptic filling, oversight of visual inspection, equipment preparation, buffer preparation) 
  • Carry out development and manufacturing activities according to predefined study plans or batch records complying to the defined timelines.
  • Carry out development and manufacturing activities according to predefined study plans or batch records complying to the defined timelines.
  • Take over assigned projects within the F&F area
  • Plan the execution of work packages and manufacturing operations as well as side activities. 
  • Establish, review and Implementation of process related procedures (Batch Records/ Standard operation procedures, Reports)
  • Document the executed work in protocols and batch records in accordance to good documentation practice.
  • Review filled out batch records and manufacturing protocols.
  • Reporting of non-conformances and initiation of quality issue records and low impact investigations as well as corrective actions under cGMP.
  • 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
  • Support Transfer and Shipment of manufactured product
  • Organization and Oversight production related process (e.g. sample management) with other departments
  • Reporting of non-conformances and initiation of quality issue records and low impact investigations as well as corrective actions under cGMP.
  • Perform Work according to EHS regulations, report EHS gaps and/or incidents and initiate EHS improvements.


Qualifications

  • Bachelor or Master Degree within the area of Biotechnology, Food Technology, Biology or similar
  • Professional work experience as process engineer or equivalent in the life sciences field in a cGMP environment.
  • Knowledge of aseptic processing and visual inspection is a plus
  • 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
  • Analytical thinking and problem-solving ability
  • Enhanced Communication ability
  • Language skills: fluent German spoken and written and good English skills.

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