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Lonza
11d ago

Trainee MSAT Validation / MSAT Process Expert(m/w/x)

Visp
Full-timeOn-site

Description

You will gain hands-on experience in microbial manufacturing by supporting process validation and quality reviews. Your day-to-day involves coordinating with stakeholders to ensure GMP compliance and project success.

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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

Education

Master's degree

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

Tools & Technologies

Continued Process Verification (CPV)Product Quality Review (PQR)GMP

Languages

English – Business Fluent

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