Thermo Fisher Scientific
Senior QA Qualification and Validation Specialist(m/w/x)
Full-timeOn-siteSenior
Lengnau
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At gene therapy manufacturer, implementing quality systems for viral vector products; monitoring aseptic manufacturing. M.Sc./PhD in Biotech/Virology and 5 years GMP biopharmaceutical experience required. 5 weeks holidays, flexible working hours.
Requirements
- M.Sc. or PhD in Biotechnology, Virology, Molecular Biology or related fields
- At least 5 years of experience in GMP-regulated biopharmaceutical environment
- Desirable in-depth knowledge of viral vector production and quality control
- Strong understanding of regulatory requirements and GMP guidelines
- Preferred experience in aseptic manufacturing (Annex 1)
- Excellent analytical and problem-solving skills
- Exceptional communication and interpersonal skills
- Proficiency with QMS software and quality management tools
- Fluency in English and German as a plus
Tasks
- Implement quality systems and QA workflows
- Support GMP facility operations
- Monitor aseptic manufacturing and environmental processes
- Serve as the primary QA contact
- Provide on-site shop floor quality support
- Review and approve batch records
- Evaluate deviation reports and quality documents
- Conduct thorough root cause analyses
- Manage and oversee CAPA processes
- Promote a culture of continuous improvement
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- QMS software
- Quality management tools
Benefits
Flexible Working
- Flexible working hours
Competitive Pay
- Competitive and attractive compensation
Informal Culture
- Dynamic, diverse, inclusive environment
- Creative freedom
Purpose-Driven Work
- Innovative gene therapy projects
Learning & Development
- Diverse skill development
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SIEGFRIED DiNAMIQS AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Full-timeOn-siteSeniorLengnau
At gene therapy manufacturer, implementing quality systems for viral vector products; monitoring aseptic manufacturing. M.Sc./PhD in Biotech/Virology and 5 years GMP biopharmaceutical experience required. 5 weeks holidays, flexible working hours.
Requirements
- M.Sc. or PhD in Biotechnology, Virology, Molecular Biology or related fields
- At least 5 years of experience in GMP-regulated biopharmaceutical environment
- Desirable in-depth knowledge of viral vector production and quality control
- Strong understanding of regulatory requirements and GMP guidelines
- Preferred experience in aseptic manufacturing (Annex 1)
- Excellent analytical and problem-solving skills
- Exceptional communication and interpersonal skills
- Proficiency with QMS software and quality management tools
- Fluency in English and German as a plus
Tasks
- Implement quality systems and QA workflows
- Support GMP facility operations
- Monitor aseptic manufacturing and environmental processes
- Serve as the primary QA contact
- Provide on-site shop floor quality support
- Review and approve batch records
- Evaluate deviation reports and quality documents
- Conduct thorough root cause analyses
- Manage and oversee CAPA processes
- Promote a culture of continuous improvement
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- QMS software
- Quality management tools
Benefits
Flexible Working
- Flexible working hours
Competitive Pay
- Competitive and attractive compensation
Informal Culture
- Dynamic, diverse, inclusive environment
- Creative freedom
Purpose-Driven Work
- Innovative gene therapy projects
Learning & Development
- Diverse skill development
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SIEGFRIED DiNAMIQS AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
SIEGFRIED DiNAMIQS AG
Industry
Pharmaceuticals
Description
The company specializes in the manufacturing of viral vector gene therapies and offers a range of services including process development and analytics.
Not a perfect match?
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