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CHCH12 Lonza AG

CSV Engineer(m/w/x)

Visp
Full-timeOn-siteSenior

Validation and commissioning of critical computerized systems for new construction and expansion projects in the life sciences industry. Significant experience in regulated environments for computerized system validation required, Delta-V knowledge preferred. Work across multiple project sites.

Requirements

  • Bachelor, Master, Diploma from a technical school, university of applied sciences, or equivalent experience
  • Significant experience in a regulated environment with regard to Computerized System Validation (CSV)
  • Good knowledge of Microsoft Office and Delta-V
  • Knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP
  • Proficiency in English, with German language skills being advantageous

Tasks

  • Generate and execute validation for computerized systems
  • Follow planning and implementation of CSV activities
  • Prepare commissioning and validation documents for new systems
  • Supervise conversion, expansion, and new construction projects
  • Conduct CSV activities for critical systems in new construction
  • Provide SLC support for all systems post debut
  • Supervise deviations, changes, and CAPAs
  • Coordinate CSV executions with internal groups and external providers
  • Present CSV documents during audits and inspections
  • Schedule and report CSV activities
  • Align CSV strategy with QA CSV for all Biologics scope
  • Contribute to the review and continuous improvement of CSV documents

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Tools & Technologies

  • Microsoft Office
  • Delta-V
  • KNEAT
  • COMOS
  • DMS
  • TrackWise
  • SAP
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