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LOLonza

Senior Scientist, Equipment Qualification(m/w/x)

Stein (AR)
Full-timeOn-siteSenior

Leading qualification of HPLC and CE systems in a GMP-controlled QC laboratory for a global medicine manufacturer. Proven experience in analytical instrument qualification and lab quality systems required. Performance-based bonuses and comprehensive family support benefits.

Requirements

  • Work experience in GMP-controlled laboratory
  • Experience in qualification of analytical instruments
  • Apprenticeship or degree in related field
  • Experience in analytical methodologies (advantageous)
  • Knowledge of lab quality systems (plus)
  • Fluency in written and spoken English
  • Language skills in German (plus)
  • Independent work in dynamic environments

Tasks

  • Lead qualification and re-qualification of analytical equipment and software
  • Manage HPLC, CE, refrigerators, and other QC laboratory systems
  • Execute performance qualifications for defined equipment
  • Train staff on equipment and related processes
  • Author and review qualification plans and reports
  • Approve documentation from external service providers
  • Ensure laboratory system compliance with cGMP and regulatory guidelines
  • Maintain systems according to standard processes and SOPs
  • Oversee equipment maintenance and qualified status
  • Perform periodic reviews of equipment qualification and calibration
  • Act as the designated system owner for defined equipment
  • Serve as a Subject Matter Expert during audits and inspections

Work Experience

approx. 4 - 6 years

Education

Vocational certificationORBachelor's degree

Languages

EnglishBusiness FluentGermanBasic

Tools & Technologies

HPLCICiefUV-VISElisaCE-SDSLIMSTiamoEmpowerChromeleon

Benefits

Bonuses & Incentives

  • Performance-based compensation programs

Corporate Discounts

  • Lifestyle benefits
  • Leisure benefits

Family Support

  • Family benefits

Career Advancement

  • Agile career

Startup Environment

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace

Other Benefits

  • Relocation assistance
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