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).
Desired Skills and Experience
Equipment Validation
ISO13485
Medical Device
IQ/OQ/PQ
CNC
Process Validation
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