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).