Manufacturing Process Specialist
Vor 2 Tagen
Company Overview
Janssen Vaccines is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide.
The Bern site acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and is recently expanding its portfolio into bacterial based therapeutic products.
Job Description
- Support routine GMP manufacturing process with focus on Downstream process steps (chromatography, Diafiltration/Ultrafiltration)
- Support routine GMP manufacturing and help in trouble shooting and process improvements
- Data verification
- Data trending
- Writing of SOP's (first draft MBR's, WorkInstructions, Equipment handling) and train Operators on those documents
- Writing of Reports (TechTransfer/Campaign) and Technical documents like Risk Assessments
- SME (Subject Matter Expert) for Quality Issues, Root Cause Analysis and Investigation
- Initiating and implementing of Change Controls
Required Skills and Qualifications
- Master or Bachelor degree in Bio-Engineering / Biotechnology / Biology / Biochemistry
- Experience in GMP compliant biotechnological manufacturing or development
- Experience in chromatography and DF/UF
- Excellent problem solving and analytical capabilities
- Knowledge in Statistic
- Team player and a personality with excellent interpersonal communication skills
- Capacity to communicate fluently in English and German
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