Lonza
Process Validation Expert MSAT(m/w/x)
Full-timeOn-siteJunior
Visp
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CHCH12 Lonza AG
MSAT Process Validation Specialist(m/w/x)
Visp
Full-timeOn-siteJunior
Nejo AI Summary
Performance qualification and continued verification for biopharmaceutical manufacturing in Mammalian Manufacturing at a global life sciences firm. Minimum 1 year in cGMP-regulated biopharmaceutical validation activities required. Global project scope, exposure to diverse regulatory frameworks.
Requirements
- Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
- Proven experience in managing complex projects
- Minimum 1 year of experience in process validation within a cGMP-regulated biopharmaceutical environment
- Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
- Good understanding of GMP
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English
Tasks
- Conduct process performance qualification activities
- Execute continued process verification tasks
- Plan, execute, and document validation protocols and reports
- Align validation activities with regulatory expectations (FDA, EMA, ICH)
- Manage technical risks associated with process validation
- Ensure project completion aligns with project management goals
- Collaborate with MSAT process experts and cross-functional teams
- Communicate critical process and technical information effectively
- Represent the company in customer meetings, audits, and inspections
- Provide technical expertise during audits and inspections
- Compile assessments of change requests and process validation deviations
- Review CMC sections in filing documents and validation reports
- Participate in continuous improvement initiatives
- Develop validation lifecycle strategies
- Implement standardized procedures for compliance across the network
- Share knowledge and information across teams and functions
Work Experience
- 1 year
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.
Not a perfect match?
- CH12 Lonza AG
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CHCH12 Lonza AG
MSAT Process Validation Specialist(m/w/x)
Visp
Full-timeOn-siteJunior
Nejo AI Summary
Performance qualification and continued verification for biopharmaceutical manufacturing in Mammalian Manufacturing at a global life sciences firm. Minimum 1 year in cGMP-regulated biopharmaceutical validation activities required. Global project scope, exposure to diverse regulatory frameworks.
Requirements
- Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
- Proven experience in managing complex projects
- Minimum 1 year of experience in process validation within a cGMP-regulated biopharmaceutical environment
- Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
- Good understanding of GMP
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English
Tasks
- Conduct process performance qualification activities
- Execute continued process verification tasks
- Plan, execute, and document validation protocols and reports
- Align validation activities with regulatory expectations (FDA, EMA, ICH)
- Manage technical risks associated with process validation
- Ensure project completion aligns with project management goals
- Collaborate with MSAT process experts and cross-functional teams
- Communicate critical process and technical information effectively
- Represent the company in customer meetings, audits, and inspections
- Provide technical expertise during audits and inspections
- Compile assessments of change requests and process validation deviations
- Review CMC sections in filing documents and validation reports
- Participate in continuous improvement initiatives
- Develop validation lifecycle strategies
- Implement standardized procedures for compliance across the network
- Share knowledge and information across teams and functions
Work Experience
- 1 year
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
Pharmaceuticals
Description
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
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