Validation Engineer (EU MDR)
Validation Engineer - EU MDR Operations
Location: Barcelona, Spain
Length: 12 months contract (freelance)
Hours: 40 hours/week (hybrid)
Start Date: ASAP
Role Overview
As a key member of the EU MDR Operations team, you will drive validation readiness, ensuring that equipment, processes, and supporting documentation meet regulatory and QMS requirements. This is a hands‑on technical role, ideal for a validation professional experienced in IQ/OQ/PQ, remediation, and audit‑driven environments.
Key Responsibilities
- Execute and support IQ/OQ/PQ validation activities for manufacturing processes and equipment
- Update and align validation protocols, reports, and rationales with EU MDR and ISO 13485
- Contribute to the remediation of legacy files, ensuring robust traceability and compliance
- Support the creation and review of validation plans, risk assessments, and engineering studies
- Collaborate with Quality, Engineering, and Regulatory teams during MDR readiness activities
- Assist with documentation for NB audits and compliance reviews
- Participate in investigations, CAPAs, and changes impacting validated processes
Requirements
- 3+ years' experience in Process / Equipment Validation in Medical Devices or Pharma
- Strong understanding of EU MDR, ISO 13485, and 21 CFR 820
- Hands‑on experience with IQ/OQ/PQ and validation documentation
- Comfortable working under tight timelines and in remediation-heavy environments
- Ability to collaborate with cross-functional teams (Engineering, QA, RA)
- Experience in automated assembly, packaging, sterilisation, or cleanroom processes is a plus
- Spanish and English fluency
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