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Single-Use Systems Expert(m/w/x)
Evaluation of filters, tubings, and bags for injectable drug products at biopharma firm with 90,000+ employees. Master’s degree in Pharmacy, Chemistry, or Biotechnology required. 14-week paid family leave, extensive childcare benefits, and long-term illness coverage.
Requirements
- Master in Pharmacy, Chemistry, or Biotechnology
- Pharmaceutical industry experience, preferably Quality Assurance
- Precise working style under pressure
- Good organization skills
- Very good German and English skills
- Profound MS-Office knowledge
- Ability to work in diverse teams
- Good communication and presentation skills
Tasks
- Evaluate single-use technology including filters, tubings, and bags
- Develop and establish new disposables for injectable drug products
- Assess Extractables, Leachables, and Filter validation
- Collect and compile necessary technical information
- Perform technical assessments based on available data
- Coordinate document review and approval within project timelines
- Plan and coordinate external Leachables and Filter Validation studies
- Collaborate closely with product teams on project needs
- Serve as primary process owner for filter validation
- Present E&L and validation topics during audits
- Share expertise within global Communities of Practice
- Support regulatory dossier preparation and Health Authority inquiries
- Assist with Change Control and Deviation processes
- Troubleshoot issues concerning Single Use Technology
- Create GMP documents including SOPs and PQ Plans
- Apply Environmental Sustainability by Design to product development
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS-Office
Benefits
Healthcare & Fitness
- High-quality healthcare
Other Benefits
- Numerous prevention programs
- Long-term illness coverage
Generous Parental Leave
- 14-week paid family leave
Childcare
- Wide range of childcare benefits
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Single-Use Systems Expert(m/w/x)
Evaluation of filters, tubings, and bags for injectable drug products at biopharma firm with 90,000+ employees. Master’s degree in Pharmacy, Chemistry, or Biotechnology required. 14-week paid family leave, extensive childcare benefits, and long-term illness coverage.
Requirements
- Master in Pharmacy, Chemistry, or Biotechnology
- Pharmaceutical industry experience, preferably Quality Assurance
- Precise working style under pressure
- Good organization skills
- Very good German and English skills
- Profound MS-Office knowledge
- Ability to work in diverse teams
- Good communication and presentation skills
Tasks
- Evaluate single-use technology including filters, tubings, and bags
- Develop and establish new disposables for injectable drug products
- Assess Extractables, Leachables, and Filter validation
- Collect and compile necessary technical information
- Perform technical assessments based on available data
- Coordinate document review and approval within project timelines
- Plan and coordinate external Leachables and Filter Validation studies
- Collaborate closely with product teams on project needs
- Serve as primary process owner for filter validation
- Present E&L and validation topics during audits
- Share expertise within global Communities of Practice
- Support regulatory dossier preparation and Health Authority inquiries
- Assist with Change Control and Deviation processes
- Troubleshoot issues concerning Single Use Technology
- Create GMP documents including SOPs and PQ Plans
- Apply Environmental Sustainability by Design to product development
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS-Office
Benefits
Healthcare & Fitness
- High-quality healthcare
Other Benefits
- Numerous prevention programs
- Long-term illness coverage
Generous Parental Leave
- 14-week paid family leave
Childcare
- Wide range of childcare benefits
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Sanofi-Aventis Deutschland GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
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