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Lonza
2d ago

MSAT Expert(m/w/x)

Stein (AR)
Full-timeOn-siteExperienced

Description

You will drive the success of aseptic fill-and-finish processes by leading technical transfers and complex projects that enhance manufacturing capabilities and ensure GMP compliance.

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Requirements

  • •Experience in aseptic/sterile drug manufacturing
  • •Know-how in sterility assurance principles
  • •Equipment qualification and cleaning validation
  • •Degree in Biotechnology, Pharmacy, or equivalent
  • •Strong communication and technical translation
  • •Proactive problem-solving and responsibility
  • •Cross-functional leadership and decision-making
  • •Proficiency in English
  • •German language skills (plus)

Education

Bachelor's degree
OR
Vocational certification

Work Experience

approx. 1 - 4 years

Tasks

  • •Lead technical transfers for aseptic fill-and-finish processes
  • •Evaluate and develop fit-for-purpose manufacturing processes
  • •Manage information transfer and process-related risks
  • •Oversee change control using structured tools
  • •Resolve technical challenges as the primary process owner
  • •Drive process monitoring and control strategies
  • •Perform complex data analyses on manufacturing processes
  • •Lead cross-functional projects to expand facility capabilities
  • •Qualify equipment, filling lines, and facilities
  • •Provide PPQ support for BLA projects
  • •Manage complex deviations and customer complaints
  • •Identify root causes using scientific and statistical insights
  • •Ensure inspection readiness for internal and external audits
  • •Support front and back-office audit activities
  • •Represent the area during facility tours
  • •Coach and mentor colleagues in project leadership
  • •Drive concept implementation across the site and network

Tools & Technologies

GMPAseptic processingSterility assuranceCleaning validationRoom qualification

Languages

English – Business Fluent

German – Basic

Benefits

Bonuses & Incentives

  • •Performance-based compensation programs

Corporate Discounts

  • •Lifestyle benefits
  • •Leisure benefits

Family Support

  • •Family benefits

Career Advancement

  • •Agile career

Informal Culture

  • •Dynamic work culture

Purpose-Driven Work

  • •Inclusive and ethical workplace

Other Benefits

  • •Relocation assistance
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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