Senior Qualification Specialist

Johnson & Johnson MedTech

Schaffhausen, Switzerland
Not specified; flexible start date.
Gmp laboratory equipment qualification
Computer system validation (csv)
Data integrity controls
Johnson & Johnson MedTech is seeking a Senior Qualification Specialist based in Schaffhausen, Switzerland, to lead qualification and computer system validation (CSV) activities for Quality Control laboratories. The ideal candidate will have extensive experience in GMP environments, particularly with laboratory equipment qualification and data integrity

Job Summary

  • Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, driving lifecycle management of analytical instruments and non-analytical utilities.
  • Author and revise WIs/SOPs related to equipment lifecycle, CSV, and data integrity, while planning and steering (re-)qualification campaigns involving multiple departments.
  • Guide and supervise cross-functional project teams, train and mentor colleagues on CSV, Annex 11/Part 11, data integrity, and qualification best practices, and support internal/external audits.

Matching Summary

Match Score: 85

Johnson & Johnson MedTech is seeking a Senior Qualification Specialist based in Schaffhausen, Switzerland, to lead qualification and computer system validation (CSV) activities for Quality Control laboratories. The ideal candidate will have extensive experience in GMP environments, particularly with laboratory equipment qualification and data integrity.

Skills & Requirements

Must-have

  • GMP laboratory equipment qualification
  • Computer System Validation (CSV)
  • Data Integrity controls
  • GAMP 5
  • 21 CFR Part 11
  • EU GMP Annex 11

Nice-to-have

  • QC quality systems and tools
  • Lab automation and integration
  • Databases, virtualization, networked systems
  • Cross-functional coordination
  • Problem-solving skills

Key Requirements

  • MSc or PhD in Natural Sciences, Engineering, Computer Science, or related field
  • Bachelor’s degree with substantial, relevant GMP experience
  • Proven experience qualifying laboratory equipment in a GMP environment
  • Hands-on CSV experience for laboratory/software systems
  • Strong documentation skills across the validation lifecycle
  • Fluent English

Work Rights

Not specified

Tailored Resume

Cover Letter