Engineer for Biologics DP

Vor 2 Tagen

Schaffhausen, Schweiz CK Group Vollzeit
Job Title:Engineer for Biologics DP / Process Validation Specialist

Work Location: Schaffhausen (Hybrid working possible)

Country: Switzerland

Duration: 1 year from start date

Rate: Up to CHF96.90 per hour all-in (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.
  • Filling line experience
  • 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.

Apply

It is essential that applicants hold entitlement to work in Switzerland.

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