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Engineer for Biologics DP - JJJP00021578
Job Posted: 23 days ago
Salary: £ 186,048/Annum
Job Type: Contract
Location: Schaffhausen
Expire in: 5 days
Job Description
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.
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