Validation Engineer


Lyon
Contract
Negotiable
Quality
CR/606045_1786953958
Validation Engineer

Validation Engineer

Location: Lyon, France (hybrid)

Start date: September 2026

Hours: Full-time

Contract length: 12 months - freelance

In this role, you will contribute to the qualification and validation of manufacturing processes, equipment, and products throughout the product lifecycle. Working closely with internal teams and external partners, you will help ensure compliance with regulatory expectations while supporting continuous quality improvement initiatives.

Key Responsibilities

    • Lead and coordinate validation activities for manufacturing processes, equipment, and medical devices throughout the product lifecycle.
    • Author, review, and approve validation protocols, reports, and supporting technical documentation.
    • Work with suppliers, contract manufacturers, and external testing partners to obtain and assess validation evidence.
    • Support risk management activities, including process risk assessments and mitigation planning.
    • Manage validation schedules and project timelines to ensure milestones and deliverables are achieved.
    • Provide validation support for change controls, process improvements, and product modifications.
    • Assist with investigations into deviations, non-conformances, complaints, and corrective actions.
    • Support internal audits, regulatory inspections, and continuous improvement initiatives to strengthen compliance and product quality.

Required Skills & Experience

  • 3+ years experience performing validation activities within a medical device environment.
  • Working knowledge of ISO 13485 and validation requirements for regulated manufacturing processes.
  • Understanding of sterilisation, cleanroom, and process validation principles.
  • Strong technical writing skills with experience producing validation and quality documentation.
  • Ability to manage multiple stakeholders, priorities, and projects while maintaining attention to detail.

FAQs

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