Qualification & Validation / Equipment Relocation Consultant

Swisslinx AG; Zürich; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Swisslinx AG in Zürich seeks an experienced Qualification & Validation Consultant to support a production equipment relocation project in the In Vitro Diagnostics (IVD) environment. You will plan, execute and document relocation, qualification, and requalification activities, ensuring GMP, ISO and regulatory compliance.

The engagement covers cross-functional coordination, risk assessments, and TrackWise documentation, with focus on ISO 13485, IVDR, GMP, GAMP 5 and FDA requirements.

Qualifikationen

• 10+ years of experience in regulated Life Sciences environments.
• Experience coordinating equipment relocation projects.
• Strong documentation and regulatory knowledge (ISO 13485, IVDR, GMP, GAMP 5, FDA).

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 and impact assessments.
• Support commissioning, qualification testing and requalification after relocation.
• Plan and execute process and cleaning validation activities.
• Manage deviations, CAPAs and Change Controls.

Kenntnisse

Life Sciences industry experience

Equipment relocation

Regulated environments

Cross-functional coordination

Tools

TrackWise Digital

Jobbeschreibung

Qualification & Validation / Equipment Relocation Consultant

We are looking for an experienced Qualification & Validation Consultant to support a production equipment relocation project within the In Vitro Diagnostics (IVD) environment.

You will support the planning, execution and documentation of equipment relocation and requalification activities, ensuring compliance with applicable GMP, ISO and regulatory requirements.

Job description:

We are looking for an experienced Qualification & Validation Consultant to support a production equipment relocation project within the In Vitro Diagnostics (IVD) environment.

You will support the planning, execution and documentation of equipment relocation and requalification activities, ensuring compliance with applicable GMP, ISO and regulatory requirements.

About the customer:

• Location: Switzerland
• Start: As soon as possible
• Duration: Approx. 6–9 months
• Workload: 80-100%

Requirements:

• 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 following equipment relocation
• Plan and execute process and cleaning validation activities
• Support CSV activities where required
• Manage deviations, CAPAs and Change Controls
• Create and maintain Change Requests, Impact Assessments and Action Items within TrackWise Digital
• Ensure complete, audit-ready documentation in accordance with ISO 13485, IVDR, GMP, GAMP 5 and FDA requirements
• Coordinate activities across cross-functional teams and support project planning, reporting and stakeholder management
• The equipment scope includes production and laboratory systems such as freeze dryers/lyophilizers, ELISA coating equipment, filling and incubation systems, cleanrooms, HVAC and purified water systems.

Competences:

• 10+ years of experience within regulated Life Sciences environments
• 5+ years of experience with equipment relocation projects
• Previous experience within Diagnostics / IVD or Medical Devices
• Strong hands‑on experience with equipment qualification and IQ/OQ/PQ
• Experience with process validation and cleaning validation
• Proven experience with TrackWise Digital
• Strong knowledge of ISO 13485, IVDR, GMP, GAMP 5, FDA 21 CFR Part 820, EU Annex 11 and Data Integrity requirements
• Experience with risk management and assessments, ideally according to ISO 14971
• Experience with freeze dryers/lyophilizers and/or ELISA coating equipment is highly advantageous
• Strong project coordination skills and experience working across multiple stakeholders and functions
• Structured, independent and quality‑focused approach with strong documentation and communication skills

Contact Information

• Swisslinx AG
  Löwenstrasse 29
  8001 Zürich

• Work location 8001 Zürich (ZH)
• Workload 35%
• Employment start By agreement
• Employment duration Temporary
• By online Online form