Lonza
MSAT Expert Drug Product(m/w/x)
Full-timeOn-siteExperienced
Visp
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TEten23 health
Senior Process Expert Aseptic Manufacturing Parenterals(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Optimizing aseptic parenteral manufacturing processes and overseeing fill-finish, filtration, and lyophilization. 5+ years sterile pharmaceutical manufacturing experience required. Annual bonus, self-responsibility.
Requirements
- University degree in Pharmacy, Biotechnology, Chemistry, Process or Mechanical Engineering, or related technical/natural science
- At least 5+ years professional experience in sterile pharmaceutical manufacturing
- Deep technical knowledge of fill-finish technology, filtration, and lyophilization
- In-depth understanding of EU-GMP Annex 1, FDA 21 CFR 210/211, and ISO cleanroom standards
- Proven experience representing technical topics during inspections and customer audits
- Strong experience in aseptic techniques, validation, and qualification
- Command of statistical methods and modern data analysis tools
- Highly structured thinker with strong technical affinity
- Capable of conducting root-cause analyses
- Capable of making independent, data-driven decisions
- Excellent communication skills in German and English
- Ability to translate complex technical concepts into clear, actionable guidance
- Resilient and responsible professional
- Team-oriented approach
- High-quality mindset
Tasks
- Provide process and compliance support for sterile parenteral manufacturing
- Optimize manufacturing processes for sterile parenteral products
- Drive continuous improvement in sterile parenteral manufacturing
- Oversee aseptic production steps
- Evaluate process data, changes, and deviations scientifically and technically
- Act as a subject matter expert in aseptic manufacturing
- Support Production and Quality Assurance
- Ensure robust, compliant, and efficient manufacturing processes
- Apply subject matter expertise in aseptic manufacturing processes
- Ensure processes are robust, validated, and regulatory-compliant
- Evaluate and optimize process parameters, equipment, technologies, and workflows
- Support the transfer of new products and processes into manufacturing
- Investigate complex deviations in the aseptic environment independently
- Conduct thorough root cause analyses
- Initiate, define, and track sustainable CAPAs
- Technically evaluate and execute process-related changes
- Support teams in the aseptic production environment
- Troubleshoot technical and process-related issues during operations
- Coach personnel on process and aseptic best practices
- Ensure process steps comply with GMP
- Support and review equipment, room, and system qualifications
- Prepare and review validation protocols and reports
- Perform technical writing and review of reports, assessments, and SOPs
- Support media-fill studies and aseptic process simulations
- Conduct trend analyses and statistical evaluations
- Monitor processes and interpret critical process parameters
- Interpret critical quality attributes
- Prepare regular process reports and provide input for PQR/APR
- Identify risks early through data analysis
- Act as a technical point of contact for audits and inspections
- Ensure audit-ready documentation is available
- Represent complex process topics and technical rationales to inspectors
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- EU-GMP Annex 1
- FDA 21 CFR 210/211
- ISO cleanroom standards
- statistical methods
- modern data analysis tools
Benefits
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
Competitive Pay
- Financial benefits
Other Benefits
- Non-financial benefits
- Mutual trust
Purpose-Driven Work
- Self-responsibility
Flexible Working
- Flexibility
Informal Culture
- Minimal bureaucracy
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health 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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TEten23 health
Senior Process Expert Aseptic Manufacturing Parenterals(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Optimizing aseptic parenteral manufacturing processes and overseeing fill-finish, filtration, and lyophilization. 5+ years sterile pharmaceutical manufacturing experience required. Annual bonus, self-responsibility.
Requirements
- University degree in Pharmacy, Biotechnology, Chemistry, Process or Mechanical Engineering, or related technical/natural science
- At least 5+ years professional experience in sterile pharmaceutical manufacturing
- Deep technical knowledge of fill-finish technology, filtration, and lyophilization
- In-depth understanding of EU-GMP Annex 1, FDA 21 CFR 210/211, and ISO cleanroom standards
- Proven experience representing technical topics during inspections and customer audits
- Strong experience in aseptic techniques, validation, and qualification
- Command of statistical methods and modern data analysis tools
- Highly structured thinker with strong technical affinity
- Capable of conducting root-cause analyses
- Capable of making independent, data-driven decisions
- Excellent communication skills in German and English
- Ability to translate complex technical concepts into clear, actionable guidance
- Resilient and responsible professional
- Team-oriented approach
- High-quality mindset
Tasks
- Provide process and compliance support for sterile parenteral manufacturing
- Optimize manufacturing processes for sterile parenteral products
- Drive continuous improvement in sterile parenteral manufacturing
- Oversee aseptic production steps
- Evaluate process data, changes, and deviations scientifically and technically
- Act as a subject matter expert in aseptic manufacturing
- Support Production and Quality Assurance
- Ensure robust, compliant, and efficient manufacturing processes
- Apply subject matter expertise in aseptic manufacturing processes
- Ensure processes are robust, validated, and regulatory-compliant
- Evaluate and optimize process parameters, equipment, technologies, and workflows
- Support the transfer of new products and processes into manufacturing
- Investigate complex deviations in the aseptic environment independently
- Conduct thorough root cause analyses
- Initiate, define, and track sustainable CAPAs
- Technically evaluate and execute process-related changes
- Support teams in the aseptic production environment
- Troubleshoot technical and process-related issues during operations
- Coach personnel on process and aseptic best practices
- Ensure process steps comply with GMP
- Support and review equipment, room, and system qualifications
- Prepare and review validation protocols and reports
- Perform technical writing and review of reports, assessments, and SOPs
- Support media-fill studies and aseptic process simulations
- Conduct trend analyses and statistical evaluations
- Monitor processes and interpret critical process parameters
- Interpret critical quality attributes
- Prepare regular process reports and provide input for PQR/APR
- Identify risks early through data analysis
- Act as a technical point of contact for audits and inspections
- Ensure audit-ready documentation is available
- Represent complex process topics and technical rationales to inspectors
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- EU-GMP Annex 1
- FDA 21 CFR 210/211
- ISO cleanroom standards
- statistical methods
- modern data analysis tools
Benefits
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
Competitive Pay
- Financial benefits
Other Benefits
- Non-financial benefits
- Mutual trust
Purpose-Driven Work
- Self-responsibility
Flexible Working
- Flexibility
Informal Culture
- Minimal bureaucracy
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health 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
ten23 health
Industry
Pharmaceuticals
Description
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
Not a perfect match?
- Lonza
MSAT Expert Drug Product(m/w/x)
Full-timeOn-siteExperiencedVisp - Lonza
USP Process Expert MSAT Microbial(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
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Full-timeOn-siteExperiencedVisp - CH12 Lonza AG
Head Manufacturing Science and Technology(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
Process Expert MSAT Downstream- Mammalian Large Scale(m/w/x)
Full-timeOn-siteManagementVisp