Lonza
Process Validation Expert MSAT(m/w/x)
Full-timeOn-siteJunior
Visp
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CHCH12 Lonza AG
Process Validation Team Lead MSAT(m/w/x)
Visp
Full-timeOn-siteManagement
Nejo AI Summary
Ensuring consistent quality in mammalian biopharmaceutical manufacturing processes, overseeing protocols and regulatory compliance. 5+ years ensuring cGMP biopharma process quality with proven leadership experience required. Global project scope, supportive team environment.
Requirements
- Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
- Proven leadership experience in managing technical teams and complex projects
- Minimum 5 years of experience in process validation within a cGMP-regulated biopharmaceutical environment
- Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
- Strong understanding of GMP
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English
Tasks
- Lead and manage the process validation team
- Create a supportive and growth-oriented team environment
- Oversee resource allocation, goal setting, and performance evaluations
- Plan, execute, and document validation protocols and reports
- Ensure compliance with regulatory expectations (FDA, EMA, ICH)
- Manage technical risks associated with process validation
- Collaborate with MSAT leaders and cross-functional teams
- Communicate critical process and technical information
- Oversee validation data for protocol acceptance criteria
- Conduct statistical analysis for CPV reporting
- Represent the company in customer meetings, audits, and inspections
- Compile assessments of change requests and validation deviations
- Review CMC sections in filing documents and validation reports
- Drive continuous improvement initiatives
- Support the development of standardized procedures for compliance
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CH12 Lonza 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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CHCH12 Lonza AG
Process Validation Team Lead MSAT(m/w/x)
Visp
Full-timeOn-siteManagement
Nejo AI Summary
Ensuring consistent quality in mammalian biopharmaceutical manufacturing processes, overseeing protocols and regulatory compliance. 5+ years ensuring cGMP biopharma process quality with proven leadership experience required. Global project scope, supportive team environment.
Requirements
- Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
- Proven leadership experience in managing technical teams and complex projects
- Minimum 5 years of experience in process validation within a cGMP-regulated biopharmaceutical environment
- Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
- Strong understanding of GMP
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English
Tasks
- Lead and manage the process validation team
- Create a supportive and growth-oriented team environment
- Oversee resource allocation, goal setting, and performance evaluations
- Plan, execute, and document validation protocols and reports
- Ensure compliance with regulatory expectations (FDA, EMA, ICH)
- Manage technical risks associated with process validation
- Collaborate with MSAT leaders and cross-functional teams
- Communicate critical process and technical information
- Oversee validation data for protocol acceptance criteria
- Conduct statistical analysis for CPV reporting
- Represent the company in customer meetings, audits, and inspections
- Compile assessments of change requests and validation deviations
- Review CMC sections in filing documents and validation reports
- Drive continuous improvement initiatives
- Support the development of standardized procedures for compliance
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CH12 Lonza 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
CH12 Lonza AG
Industry
Healthcare
Description
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Not a perfect match?
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