Validation Lead

Hero Recruitment Group; Connacht; On-site; EUR 85,000 - 115,000; Full time

Job summary

Hero Recruitment Group is partnering with a leading medical device manufacturer to appoint a Validation Lead on site. You will lead a team of Validation Quality Engineers, oversee planning, execution, and documentation of validation activities supporting new product introductions and change control.

The role requires 8–12 years of experience in regulated environments, strong ISO 13485 and FDA knowledge, and proven leadership.

Qualifications

• 8–12 years' experience in validation, quality engineering, or a related role within a regulated industry.
• Experience in medical device, pharmaceutical, or similarly regulated manufacturing environments.
• Prior experience leading or supervising technical or quality teams.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Parts 820/11.
• Experience with audits and regulatory inspections.

Responsibilities

• Lead and supervise a team of Validation Quality Engineers.
• Plan and coordinate validation of equipment, processes, and tests.
• Ensure activities comply with internal procedures and regulatory standards.
• Review and approve validation documentation (plans, protocols, reports, deviations).
• Allocate resources and manage timelines to meet project schedules.
• Liaise with Design Assurance, R&D, Engineering, Manufacturing, Supply Chain, and Quality.
• Support compliance activities including internal audits and CAPA.
• Identify and drive continuous improvement in validation processes.
• Apply problem-solving and risk-based decision making in manufacturing.
• Communicate complex technical information to diverse stakeholders, including senior leadership.

Skills

Team leadership

Regulatory knowledge

Problem solving

Communication

Risk-based decision making

Education

Bachelor's degree in Engineering, Science, or related

Tools

Statistical analysis tools

Job description

Validation Lead

Our client, a leading medical device manufacturer, is looking for a Validation Lead to lead a site-based team of Validation & Quality Engineers.

This role is accountable for the effective planning, coordination, and execution of equipment and process validation activities supporting new product introductions, change control, and strategic initiatives.

In this role you will :

• Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring, and performance guidance.
• Plan and coordinate execution of equipment, process, and test method validations supporting new product development, change control, and strategic initiatives.
• Ensure validation activities are performed in accordance with internal procedures, regulatory requirements, and industry best practices.
• Review and approve validation documentation, including validation plans, risk assessments, protocols, reports, and deviation or exception documentation.
• Allocate resources and manage timelines to support project schedules and operational priorities.
• Act as site validation liaison with Design Assurance, R&D, Engineering, Manufacturing Operations, Supply Chain, and Quality functions.
• Support compliance activities including internal audits, inspections, and CAPA processes.
• Identify and drive continuous improvement opportunities related to validation processes, standard work, and compliance practices.
• Apply problem-solving, critical thinking, and risk-based decision-making in a dynamic manufacturing environment.
• Communicate complex technical information clearly to diverse stakeholders, including senior leadership

Ideally you will have:

• Bachelor's degree in Engineering, Science, or a related discipline, or equivalent experience.
• 8–12 years' experience in validation, quality engineering, or a related role within a regulated industry.
• Demonstrated experience working in medical device, pharmaceutical, or similarly regulated manufacturing environments.
• Prior experience leading or supervising technical or quality teams is required.
• Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and related regulatory standards.
• Experience with statistical analysis and validation tools.
• Demonstrated experience supporting audits and regulatory inspections.