Validation Specialist
Validation Specialist - Medical Devices (Contract)
- Duration: 1 year contract (Extension possible)
- Hours: 40 hours per week
- Start Date: ASAP
- Work Model: Hybrid
- Location: Cork, Ireland
Role Overview
We are seeking an experienced Validation Specialist to support equipment, process, and manufacturing validation activities within a regulated medical device environment. This role will focus on the planning, execution, and documentation of validation activities to support new and existing manufacturing processes, with a strong emphasis on execution excellence and compliance with regulatory and quality standards.
The successful contractor will work cross-functionally with Engineering, Quality, Manufacturing, and external vendors to ensure equipment and processes are installed, qualified, and validated in line with project and business requirements.
Key Responsibilities
Validation & Qualification
- Plan, execute, and document IQ/OQ/PQ protocols for manufacturing and process equipment in accordance with regulatory requirements (FDA, EU MDR, ISO standards).
- Support equipment validation from delivery through installation, commissioning, qualification, and handover to operations.
- Execute process validation activities, including protocol execution, sampling, data collection, deviation management, and summary reporting.
- Ensure validation activities meet approved timelines, quality standards, and regulatory expectations.
Equipment & Manufacturing Support
- Support CNC operations and associated validation activities within a manufacturing environment.
- Coordinate equipment delivery, installation, and vendor activities to support qualification schedules.
- Work closely with equipment suppliers and internal stakeholders to resolve technical or validation-related issues.
- Support change management activities related to equipment upgrades, process changes, or new introductions.
Compliance & Documentation
- Generate and review validation documentation, including protocols, reports, traceability matrices, and risk assessments.
- Ensure all activities are performed in compliance with site procedures, GMP requirements, and regulatory guidelines.
- Participate in audits and inspections as required, providing validation support and documentation.
Collaboration & Project Support
- Liaise with Engineering, Quality, Manufacturing, and Project teams to ensure alignment on validation deliverables.
- Proactively track and manage validation tasks to agreed project milestones.
- Identify risks and propose mitigation actions to support successful validation execution.
Required Experience & Skills
Essential
- Proven experience in equipment and process validation within a medical device or regulated manufacturing environment.
- Hands-on experience executing IQ, OQ, and PQ protocols.
- Strong understanding of GMP, FDA, EU MDR, and ISO standards.
- Experience supporting CNC machinery or automated manufacturing equipment.
- Ability to independently execute validation activities and manage documentation to completion.
- Strong attention to detail and excellent documentation skills.
Desirable
- Experience working on sustained manufacturing or new equipment introduction projects.
- Familiarity with manufacturing execution systems and validation lifecycle management.
- Previous contract experience in a medical device or pharmaceutical environment.
Education
- Degree in Engineering, Science, or a related technical discipline (or equivalent experience).
FAQs
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