Process Validation Scientist

Posted 4 hours 52 minutes ago by CK Group

Permanent
Not Specified
Other
Not Specified, Switzerland
Job Description
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.

Apply

It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.