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LOLonza

MSAT Bioconjugates Cleaning Validation Expert(m/w/x)

Visp
Full-timeOn-siteExperienced

Defining cleaning validation strategy for bioconjugates manufacturing at a global life sciences leader. Master/PhD in bioconjugation, biotechnology, or related life science discipline required. Relocation assistance provided.

Requirements

  • Master or PhD in bioconjugation, biotechnology, chemical engineering, organic chemistry or life science discipline
  • Preferred industrial experience in GMP environment (>3 years) in bioconjugation, biopharma manufacturing, BioConjugates or DSP
  • Advantageous experience in cleaning validation and with regulatory agencies
  • Excellent communication skills
  • Proficiency in English and advantageous knowledge of German
  • Motivation, creativity, agility and open-mindedness
  • Strong team orientation and solution-oriented working
  • Eagerness to foster teamwork and inclusion

Tasks

  • Define and design the site's cleaning validation strategy
  • Ensure scientific robustness and regulatory compliance
  • Collaborate with QA and Operations on asset improvements
  • Lead cleaning validation campaign preparations
  • Author protocols and review FMEAs and QC studies
  • Assess deviations and investigations during campaign execution
  • Evaluate data against defined acceptance criteria
  • Manage all cleaning validation documentation and SOPs
  • Maintain the facility and product validation matrix
  • Monitor and implement evolving regulatory requirements
  • Respond to health authority questions during inspections
  • Support batch release and define corrective actions

Work Experience

  • 3 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Tools & Technologies

  • GMP
  • bioconjugation
  • DSP
  • Mammalian
  • Microbial
  • Swissmedic
  • FDA

Benefits

Other Benefits

  • Relocation assistance

Career Advancement

  • Agile career

Informal Culture

  • Dynamic working culture
  • Highly collaborative environment
  • Teamwork and inclusion

Learning & Development

  • Professional development programs

Purpose-Driven Work

  • Ethical workplace

Bonuses & Incentives

  • Performance-based compensation programs
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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