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Lead Technician GMP Operations (Fill & Finish), Ref.: 2105917827W, Location: Berne, 100% Pensum

Johnson & Johnson
place
Berne

4W

Online bewerbenopen_in_new

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.

Lead Technician GMP Operations (Fill & Finish), Ref.: 2105917827W, Location: Berne, 100% Pensum

YOUR responsibilities & YOUR impact:

  • Execution of the practical project work within a cGMP regulated environment. To a lead technician 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, 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.
  • Generation and update of manufacturing and process supportive documentation.
  • Document the executed work in protocols and batch records in accordance to good documentation practice.
  • Review filled out batch records and manufacturing protocols.
  • Plan the execution of work packages and manufacturing operations as well as side activities. 
  • Take part in establishment and provide feedback to study plans, study reports, work instructions, batch records, technical and equipment maintenance/calibration reports.
  • Internal organization of assigned pilot plant facility suites including implementation of safety relevant procedures as well as house-keeping activities (log books, cleaning protocols, etc.) in accordance to cGMP regulations.
  • Reporting of non-conformances and initiation of quality issue records and low impact investigations as well as corrective actions under cGMP.
  • Implementation and introduction of new processing techniques and manufacturing equipment and/or coordination of equipment improvements and modifications.
  • Support preparation of engineering specifications and documentation for simple manufacturing equipment; communication with external parties for purchasing of and commissioning of new equipment
  • Support Qualification and Validation activities related to Fill&Finish processes, equipment/ rooms
  • Support Transfer and Shipment of manufactured product
  • Organization and Oversight production related process (e.g. sample management) with other departments 
  • Perform Work according to EHS regulations, report EHS gaps and/or incidents and initiate EHS improvements.

 We would love to hear from YOU, if you have:

  • Bachelor Degree within the area of Biotechnology, Food Technology, Biology or similar 
  • Professional work experience as technician with leading responsibilities 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
  • Basic Knowledge of Regulatory Principles
  • Good documentation practice
  • Language skills: fluent German spoken and written and good English skills.

This is what awaits YOU at J&J:

  • An opportunity to be part of a global market leader.
  • A dynamic and inspiring working environment.
  • Many opportunities to work on challenging projects and assignments.
  • Possibilities for further personal as well as professional development.
  • Many employees benefits.