CH12 Lonza AG
MSAT Process Validation Specialist(m/w/x)
Full-timeOn-siteJunior
Visp
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Conducting performance qualification and continued verification for mammalian biopharma products. Minimum 1 year experience with cGMP biopharma process lifecycle management required. Work in a global life sciences setting.
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 validation deviations
- Review CMC sections in filing documents and validation reports
- Participate in continuous improvement initiatives
- Develop and implement standardized procedures for compliance
- Share information and knowledge 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 Lonza 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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Conducting performance qualification and continued verification for mammalian biopharma products. Minimum 1 year experience with cGMP biopharma process lifecycle management required. Work in a global life sciences setting.
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 validation deviations
- Review CMC sections in filing documents and validation reports
- Participate in continuous improvement initiatives
- Develop and implement standardized procedures for compliance
- Share information and knowledge 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 Lonza 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
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- CH12 Lonza AG
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