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.

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