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Trainee MSAT Validation / MSAT Process Expert(m/w/x)
Continuous Process Validation and Product Quality Review for microbial manufacturing at a global biopharmaceutical CDMO. Degree in Biotechnology, Chemistry, or Engineering with microbial process knowledge required. Structured career start in a specialized scientific field.
Requirements
- Degree in Biotechnology, Chemistry, Engineering, or related
- Interest in microbial manufacturing and lifecycle management
- Basic understanding of bioprocess fundamentals
- Knowledge of microbial upstream or downstream processes
- Understanding of process parameters and product quality
- Knowledge of process validation principles
- Understanding of validation lifecycle concepts
- Knowledge of Continued Process Verification (CPV)
- Experience with Product Quality Review activities
- Basic knowledge of statistics
- Understanding of data trending and variability
- Ability to interpret process and quality data
- Ability to support process monitoring activities
- Interest in GMP environments and regulated manufacturing
- Good organizational and planning skills
- Effective teamwork in cross-functional environments
- Structured, analytical mindset and problem-solving orientation
- Attention to detail and data integrity interest
- Good knowledge of English
Tasks
- Plan and coordinate Continuous Process Validation activities
- Support annual Product Quality Review for assigned products
- Define and track project timelines and milestones
- Coordinate document reviews with cross-functional stakeholders
- Draft and finalize CPV and PQR reports
- Ensure data consistency and GMP compliance
- Monitor activity progress to identify potential roadblocks
- Escalate risks to the MSAT lead
- Analyze and trend data related to process validation
- Support MSAT projects throughout the entire lifecycle
- Resolve manufacturing process issues within regulatory guidelines
- Execute GMP risk analyses for manufacturing processes
- Interact with customers regarding batch status and performance
- Compile process deviations and change requests
- Support initiatives for continuous process improvement
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Continued Process Verification (CPV)
- Product Quality Review (PQR)
- GMP
Not a perfect match?
- LonzaFull-timeOn-siteJuniorVisp
- CH12 Lonza AG
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MSAT Validation Internship(m/w/x)
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Trainee MSAT Validation / MSAT Process Expert(m/w/x)
Continuous Process Validation and Product Quality Review for microbial manufacturing at a global biopharmaceutical CDMO. Degree in Biotechnology, Chemistry, or Engineering with microbial process knowledge required. Structured career start in a specialized scientific field.
Requirements
- Degree in Biotechnology, Chemistry, Engineering, or related
- Interest in microbial manufacturing and lifecycle management
- Basic understanding of bioprocess fundamentals
- Knowledge of microbial upstream or downstream processes
- Understanding of process parameters and product quality
- Knowledge of process validation principles
- Understanding of validation lifecycle concepts
- Knowledge of Continued Process Verification (CPV)
- Experience with Product Quality Review activities
- Basic knowledge of statistics
- Understanding of data trending and variability
- Ability to interpret process and quality data
- Ability to support process monitoring activities
- Interest in GMP environments and regulated manufacturing
- Good organizational and planning skills
- Effective teamwork in cross-functional environments
- Structured, analytical mindset and problem-solving orientation
- Attention to detail and data integrity interest
- Good knowledge of English
Tasks
- Plan and coordinate Continuous Process Validation activities
- Support annual Product Quality Review for assigned products
- Define and track project timelines and milestones
- Coordinate document reviews with cross-functional stakeholders
- Draft and finalize CPV and PQR reports
- Ensure data consistency and GMP compliance
- Monitor activity progress to identify potential roadblocks
- Escalate risks to the MSAT lead
- Analyze and trend data related to process validation
- Support MSAT projects throughout the entire lifecycle
- Resolve manufacturing process issues within regulatory guidelines
- Execute GMP risk analyses for manufacturing processes
- Interact with customers regarding batch status and performance
- Compile process deviations and change requests
- Support initiatives for continuous process improvement
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Continued Process Verification (CPV)
- Product Quality Review (PQR)
- GMP
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?
- Lonza
Process Validation Expert MSAT(m/w/x)
Full-timeOn-siteJuniorVisp - CH12 Lonza AG
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MSAT Expert Drug Product(m/w/x)
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