Engineer for Biologics DP - JJJP
Posted 1 day 1 hour ago by CK Group
Permanent
Not Specified
Other
Schaffhausen, Schaffhausen, Switzerland
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:
Additional duties will include:
Your Background:
Language requirements:
Fluent in English, with good communication skills in English.
Apply
It is essential that applicants hold entitlement to work in Switzerland.
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.
- 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.