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Process Validation Scientist

Process Validation Scientist

CK GroupSwitzerland
Il y a plus de 30 jours
Salaire
96,90 CHF par heure
Description de poste

Process Validation Scientist

Job Title : Process Validation Scientist

Work Location : Schaffhausen (Hybrid working possible)

Country : Switzerland

Duration : 1 year from start

Rate : Up to CHF96.90 per hour (8 hours per day) depending on experience

Your main duties as a Process Validation Scientist will include :

  • Mapping out the tech transfer (manufacturing process and equipment) strategy of late-stage biologics / large-molecules DPs to the parenteral manufacturing site.
  • Supporting the strategy and execution of Technology Transfers and Process Performance Qualification (process validation) of large molecule programs.
  • Providing the regulatory insight and support the DP leads to effectively deliver qualification of equipment, aseptic process simulation, processing / hold times, and manufacturing processes.

Additional duties will include :

  • Authoring, reviewing, and approving technical and regulatory documents (e.g., batch records, validation protocols, control strategy, and reports).
  • Supporting DP Process Performance Qualification and preparation of regulatory reports.
  • Supporting the internal and external teams in qualification of DP manufacturing equipment.

    • Your Background :

  • Scientist, MSc or equivalent in a technical field such as Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering.
  • 4 years of experience in biopharmaceuticals or bachelor’s degree + 8 years of experience.
  • Expertise in ICH quality guidelines and late-stage biologic DP manufacturing.
  • Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable.
  • Experience in technology transfers projects.

    • Proven track record in at least 3 of these areas :

  • DP comparability.
  • Equipment qualification.
  • Pharmaceutical process development.
  • Technology transfer.
  • Process validation.

    • Language requirements :

    Fluent in English, with good communication skills in English.