CH12 Lonza AG
Senior Quality Excellence Manager(m/w/x)
Full-timeWith HomeofficeSenior
Visp
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CHCH12 Lonza AG
Senior Process Validation Expert(m/w/x)
Visp
Full-timeWith Home OfficeSenior
Nejo AI Summary
Developing process validation strategies, authoring protocols, and conducting hold time/resin lifetime assessments at global biopharma leader. cGMP biopharma process validation experience, including complex project management, required. Cross-functional team collaboration.
Requirements
- Master’s or PhD degree in biotechnology, life sciences, or related disciplines
- Working experience in process validation within a cGMP-regulated biopharmaceutical environment
- Proven experience in managing complex projects, ideally in MSAT or Quality
- Ability to manage multiple tasks and meet deadlines effectively
- Strong understanding of upstream and downstream processes, preferably in mammalian manufacturing
- Exposure to process development, scale-up, and/or manufacturing, preferably mammalian cell culture
- Experience engaging with regulatory agencies (Swissmedic, FDA, etc.)
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English (written and spoken); German is an advantage
- Able to come on site in Visp 60% of the time
Tasks
- Develop process validation strategies for assigned projects
- Prepare and author process validation protocols and reports
- Conduct supporting studies, including hold time and resin lifetime assessments
- Support Process Development teams during process characterization
- Maintain a detailed continued process verification plan
- Assess and approve Product Quality Reviews
- Review and approve process-related documents
- Evaluate process validation data against acceptance criteria
- Support investigations of deviations and approve deviation reports
- Act as a Subject Matter Expert for non-conformity records and change requests
- Represent Lonza in customer-facing meetings
- Assist in developing programs and Standard Operating Procedures to meet industry standards
- Act as process validation SME during inspections and audits
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
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
Senior Process Validation Expert(m/w/x)
Visp
Full-timeWith Home OfficeSenior
Nejo AI Summary
Developing process validation strategies, authoring protocols, and conducting hold time/resin lifetime assessments at global biopharma leader. cGMP biopharma process validation experience, including complex project management, required. Cross-functional team collaboration.
Requirements
- Master’s or PhD degree in biotechnology, life sciences, or related disciplines
- Working experience in process validation within a cGMP-regulated biopharmaceutical environment
- Proven experience in managing complex projects, ideally in MSAT or Quality
- Ability to manage multiple tasks and meet deadlines effectively
- Strong understanding of upstream and downstream processes, preferably in mammalian manufacturing
- Exposure to process development, scale-up, and/or manufacturing, preferably mammalian cell culture
- Experience engaging with regulatory agencies (Swissmedic, FDA, etc.)
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English (written and spoken); German is an advantage
- Able to come on site in Visp 60% of the time
Tasks
- Develop process validation strategies for assigned projects
- Prepare and author process validation protocols and reports
- Conduct supporting studies, including hold time and resin lifetime assessments
- Support Process Development teams during process characterization
- Maintain a detailed continued process verification plan
- Assess and approve Product Quality Reviews
- Review and approve process-related documents
- Evaluate process validation data against acceptance criteria
- Support investigations of deviations and approve deviation reports
- Act as a Subject Matter Expert for non-conformity records and change requests
- Represent Lonza in customer-facing meetings
- Assist in developing programs and Standard Operating Procedures to meet industry standards
- Act as process validation SME during inspections and audits
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
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
Pharmaceuticals
Description
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
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