Associate Quality Engineer
Biogen
Luterbach, Switzerland
vor 2 Tg.

Job Description

1. You provide support to manufacturing areas within the facility for upcoming deviations and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets / agencies.

2. You review and approve simple to moderate GMP documentation (Changes, plans, protocols, technical documentation, etc.

related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory and Biogen Quality and Process systems .

3. In addition, you support ongoing production and maintenance processes reviewing and approving related work orders in the electronic maintenance management system (EMMS).

4. You work with the senior Quality Engineering Team to identify / revise / develop and implement complex Quality systems that can be global in scope.

5. You ensure adherence to internal procedures for facility / equipment controls and release before, during and after production operations (i.

e. routine operations, shutdowns, construction projects, product changeover, etc.)

Qualifications

  • You have a bachelor’s Degree in a relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer Science
  • You bring a first experience in a pharmaceutical or biotech manufacturing environment. With at least a solid previous experience within Quality Assurance, Validation or another related function
  • You have and maintain knowledge of relevant FDA / EMA regulations and compliance .
  • You have experience in validation of production equipment, automation systems and knowledge of production methodology involved in bio-pharmaceutical production.
  • You have the ability to work in cross-functional teams
  • Melde diesen Job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Bewerben
    E-Mail
    Klicke auf "Weiter", um unseren Datenschutz-und Nutzungsbestimmungen zuzustimmen . Du kriegst außerdem die besten Jobs als E-Mail-Alert. Los geht's!
    Weiter
    Bewerbungsformular