CK QLS is recruiting for a Qualification & Validation Specialist to support GMP qualification and validation activities across laboratory instruments, manufacturing equipment, cleanroom equipment, utilities and facilities.
The role
- Prepare, review and execute qualification and validation protocols, reports and assessments.
- Provide oversight of Computer System Validation (CSV) activities within manufacturing and quality environments.
- Ensure compliance with cGMP, regulatory requirements and company standards.
- Collaborate with Production, QC and Engineering teams.
- Review technical assessments, deviations, CAPAs and change controls.
- Support audits, inspections and improvements to qualification and validation processes.
Your background
- Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology or a related discipline.
- Minimum five years’ experience in qualification and validation.
- Hands-on CSV experience and strong knowledge of GMP/cGMP principles.
- Strong documentation, analytical and problem-solving skills.
- English and German proficiency at B1 level or above.
- Experience with GAMP 5, Annex 11, Annex 15, data integrity, Veeva Vault and Kneat would be advantageous.
All applicants must have valid work permit to work in Switzerland
#J-18808-Ljbffr
System Validation Engineer in Luzern Arbeitgeber: CK QLS
Als Arbeitgeber bietet unser Unternehmen eine dynamische und unterstützende Arbeitsumgebung, die Innovation und kontinuierliches Lernen fördert. Unsere Mitarbeiter profitieren von umfangreichen Entwicklungsmöglichkeiten und einem starken Fokus auf Teamarbeit, während sie an spannenden Projekten im Bereich der Technologieübertragung arbeiten. Zudem legen wir großen Wert auf Qualität, Sicherheit und Compliance, was unsere Mitarbeiter in ihrer täglichen Arbeit unterstützt und ihnen ermöglicht, einen bedeutenden Beitrag zur Weiterentwicklung unserer Produkte zu leisten.
