Validation Engineer

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.