Lonza
MSAT Expert(m/w/x)
Full-timeOn-siteExperienced
Stein (AR)
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Supporting commercial readiness for large-scale aseptic fill&finish facilities and capital investment projects. Significant aseptic/sterile fill&finish experience in GMP required. Relocation assistance, agile career path.
Requirements
- University degree or equivalent technical education in Biotechnology, Pharmacy, or related field
- Significant experience in aseptic/sterile fill&finish processes of drug products in GMP environment
- Substantial know-how in aseptic processing and sterility assurance principles
- Experience in qualification of manufacturing equipment
- Experience in cleaning validation
- Experience in room qualification
- Strong communication skills
- Ability to translate complex technical topics into clear actionable messages
- Proactive, positive approach
- Problem-solving attitude
- Ability to take full responsibility for assigned areas
- Ability to lead cross-functional teams
- Ability to drive decision-making in a matrix organization
- Ability to build strong networks and trust across internal and external stakeholders
- Proficiency in English
- German language skills
Tasks
- Support commercial readiness for large-scale aseptic fill&finish facility
- Act as MSAT Expert in capital investment projects
- Build and commission manufacturing units
- Ensure commercial readiness for GMP manufacturing facility
- Define qualification strategies for DP manufacturing equipment
- Align qualification concepts with regulatory requirements
- Lead cross-functional project teams
- Provide technical leadership in sterile manufacturing process design
- Design cleanroom layout, material/personnel flow, and equipment placement
- Craft Aseptic Process Simulation concept
- Align APS with internal guidelines and regulatory requirements
- Provide oversight during APS execution
- Support technical investigations of aseptic manufacturing process
- Develop aseptic technique training programs
- Lead risk assessments (e.g., FMEA)
- Identify critical manufacturing process parameters
- Develop control strategies for the facility
- Author and review GMP documents
- Create Qualification/Validation master plans, protocols, and reports
- Develop SOPs and manufacturing concepts
- Ensure GMP documentation readiness for authority inspections
- Contribute to standardized MSAT procedures
- Implement qualification standards
- Develop single-use systems and filtration systems
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Native
- German – Basic
Benefits
Other Benefits
- Relocation assistance
Career Advancement
- Agile career
Startup Environment
- Dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
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.
Not a perfect match?
- CH12 Lonza AG
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Supporting commercial readiness for large-scale aseptic fill&finish facilities and capital investment projects. Significant aseptic/sterile fill&finish experience in GMP required. Relocation assistance, agile career path.
Requirements
- University degree or equivalent technical education in Biotechnology, Pharmacy, or related field
- Significant experience in aseptic/sterile fill&finish processes of drug products in GMP environment
- Substantial know-how in aseptic processing and sterility assurance principles
- Experience in qualification of manufacturing equipment
- Experience in cleaning validation
- Experience in room qualification
- Strong communication skills
- Ability to translate complex technical topics into clear actionable messages
- Proactive, positive approach
- Problem-solving attitude
- Ability to take full responsibility for assigned areas
- Ability to lead cross-functional teams
- Ability to drive decision-making in a matrix organization
- Ability to build strong networks and trust across internal and external stakeholders
- Proficiency in English
- German language skills
Tasks
- Support commercial readiness for large-scale aseptic fill&finish facility
- Act as MSAT Expert in capital investment projects
- Build and commission manufacturing units
- Ensure commercial readiness for GMP manufacturing facility
- Define qualification strategies for DP manufacturing equipment
- Align qualification concepts with regulatory requirements
- Lead cross-functional project teams
- Provide technical leadership in sterile manufacturing process design
- Design cleanroom layout, material/personnel flow, and equipment placement
- Craft Aseptic Process Simulation concept
- Align APS with internal guidelines and regulatory requirements
- Provide oversight during APS execution
- Support technical investigations of aseptic manufacturing process
- Develop aseptic technique training programs
- Lead risk assessments (e.g., FMEA)
- Identify critical manufacturing process parameters
- Develop control strategies for the facility
- Author and review GMP documents
- Create Qualification/Validation master plans, protocols, and reports
- Develop SOPs and manufacturing concepts
- Ensure GMP documentation readiness for authority inspections
- Contribute to standardized MSAT procedures
- Implement qualification standards
- Develop single-use systems and filtration systems
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Native
- German – Basic
Benefits
Other Benefits
- Relocation assistance
Career Advancement
- Agile career
Startup Environment
- Dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
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?
- Lonza
MSAT Expert(m/w/x)
Full-timeOn-siteExperiencedStein (AR) - CH12 Lonza AG
Process Expert - sterile filling of biopharmaceutical Drug Product(m/w/x)
Full-timeOn-siteExperiencedStein (AR) - CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Full-timeOn-siteSeniorStein (AR) - Lonza
Process Expert - prefilled Syringes(m/w/x)
Full-timeOn-siteExperiencedStein (AR) - CH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Full-timeOn-siteSeniorStein (AR)