Validation Engineer

EPM Scientific; Lyon; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

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

Key responsibilities include leading validation activities, authoring validation protocols and reports, collaborating with suppliers and contract manufacturers, and supporting

Qualifications

• 3+ years of validation experience in medical device environments.
• Knowledge of ISO 13485 and regulatory validation requirements.
• Understanding sterilisation, cleanroom, and process validation principles.
• Strong technical writing skills for validation documentation.
• Ability to manage multiple stakeholders and projects.

Responsabilités

• Lead and coordinate validation activities for manufacturing processes, equipment and devices across the product lifecycle.
• Author, review and approve validation protocols, reports and supporting technical documentation.
• Collaborate with suppliers, contract manufacturers and testing partners to obtain validation evidence.
• Support risk management activities, including process risk assessments and mitigation planning.
• Manage validation schedules and project timelines to meet milestones.
• Provide validation support for change controls and process improvements.
• Assist with investigations into deviations, non-conformances and corrective actions.
• Support internal audits, regulatory inspections and continuous improvement initiatives.

Connaissances

Validation

Medical devices

ISO 13485

Technical writing

Stakeholder mgmt

Description du poste

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.