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.
Apply
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 107 996 in all correspondence.
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