IVD Equipment Relocation & Validation Specialist

Job-Room; Zürich; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Swisslinx AG is seeking an experienced Qualification & Validation Consultant to support an equipment relocation project in the IVD environment. You will plan, execute and document relocation, qualification and validation activities to ensure GMP/ISO compliance.

Requirements include 10+ years in regulated Life Sciences, experience with DQ/IQ/OQ/PQ, TrackWise Digital, and risk assessments. Strong cross-functional collaboration and documentation skills are essential for success in this role.

Qualifikationen

• 10+ years of experience in regulated Life Sciences environments.
• 5+ years with equipment relocation projects.
• Experience in Diagnostics/IVD or Medical Devices.
• Hands-on equipment qualification IQ/OQ/PQ.
• Process and cleaning validation experience.
• Experience with TrackWise Digital.
• Knowledge of ISO 13485, IVDR, GMP, GAMP 5, FDA 21 CFR Part 820, EU Annex 11 and Data Integrity.
• Experience with ISO 14971 risk management.
• Familiarity with freeze dryers/lyophilizers or ELISA coating equipment.
• Strong coordination across stakeholders.
• Structured, independent documentation skills.

Aufgaben

• Plan and coordinate equipment relocation, qualification and validation activities.
• Develop and execute DQ, IQ, OQ and PQ documentation.
• Prepare relocation and validation strategies, risk assessments, FMEAs, gap and impact assessments.
• Support commissioning, qualification testing and requalification after relocation.
• Plan and execute process and cleaning validation.
• Support CSV activities.
• Manage deviations, CAPAs and Change Controls.
• Create and maintain Change Requests, Impact Assessments and Action Items within TrackWise Digital.
• Ensure audit-ready documentation per ISO 13485, IVDR, GMP, GAMP 5 and FDA requirements.
• Coordinate activities across cross-functional teams and assist project planning and stakeholder management.

Kenntnisse

Life Sciences experience

Equipment relocation

Documentation

Project coordination

Cross-functional teamwork

Tools

TrackWise Digital

Jobbeschreibung

Swisslinx AG is seeking an experienced Qualification & Validation Consultant to support an equipment relocation project in the IVD environment. You will plan, execute and document relocation, qualification and validation activities to ensure GMP/ISO compliance.

Requirements include 10+ years in regulated Life Sciences, experience with DQ/IQ/OQ/PQ, TrackWise Digital, and risk assessments. Strong cross-functional collaboration and documentation skills are essential for success in this role.