Johnson & Johnson Innovative Medicine is seeking a Senior Qualification Specialist to lead qualification and CSV activities for QC laboratories at their Schaffhausen site
Job Summary
Johnson & Johnson Innovative Medicine is seeking a Senior Qualification Specialist to lead qualification and CSV activities for QC laboratories at their Schaffhausen site.
The role involves managing lifecycle of analytical instruments and utilities, ensuring data integrity, authoring validation documentation, and supporting audits and inspections.
The position offers a high-impact role within a global healthcare leader with an inclusive, collaborative environment and strong support for work-life balance.
Matching Summary
Johnson & Johnson Innovative Medicine is seeking a Senior Qualification Specialist to lead qualification and CSV activities for QC laboratories at their Schaffhausen site.
Skills & Requirements
Must-have
GMP laboratory equipment qualification
Computer system validation (CSV)
Data integrity controls
Cross-functional project coordination
Regulatory compliance with GAMP 5 and 21 CFR Part 11
Documentation of validation lifecycle
Nice-to-have
Experience with TrackWise and SAP
Knowledge of virtualization and networked lab systems
Lab automation and analytical platform integration
Fluent English with German B1 or higher
Training and mentoring skills
Key Requirements
MSc or PhD in Natural Sciences, Engineering, or Computer Science
Proven GMP experience qualifying lab equipment with and without software
Hands-on CSV experience per GAMP 5, 21 CFR Part 11, EU GMP Annex 11
Strong documentation skills for validation lifecycle