Validation Supervisor

HERO Recruitment Ltd.; Ballina; On-site; EUR 70,000 - 110,000; Full time

Job summary

HERO Recruitment Ltd. is seeking a Validation Supervisor to lead a site-based team of Validation Quality Engineers in Ballina.

You will plan, coordinate, and execute equipment and process validations to support new product introductions, changes, and strategic initiatives, ensuring compliance with the Quality Management System. The role requires strong regulatory knowledge (ISO 13485, FDA 21 CFR Parts 820/11), problem-solving skills, and the ability to communicate complex technical information

Qualifications

• Bachelor's degree in Engineering, Science, or related discipline, or equivalent experience.
• 8–12 years' experience in validation or quality engineering within regulated industry.
• Experience in medical device/pharma manufacturing environments.
• Experience leading or supervising technical or quality teams.
• Strong knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and related standards.
• Experience with statistical analysis and validation methods.
• CQE or equivalent certification is a plus.

Responsibilities

• Lead and develop a site validation team of engineers.
• Plan and coordinate equipment, process, and test method validations.
• Ensure activities comply with internal procedures and regulatory standards.
• Review and approve validation docs (plans, protocols, reports, deviations).
• Allocate resources and manage timelines for projects.
• Collaborate with Design Assurance, R&D, Engineering, Manufacturing, QA.
• Support audits, inspections, CAPA, and continuous improvement initiatives.

Skills

Team leadership

Quality engineering

Validation expertise

Regulatory compliance

Risk assessment

Statistical analysis

Problem solving

Communication

Education

Bachelor's degree in Engineering/Science

CQE certification (advantage)

Job description

Validation Supervisor

Our client, a leading medical device manufacturer, is seeking a Validation Supervisor 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. You'll partner closely with Design Assurance, Engineering, Manufacturing, and Quality teams to ensure validation activities are executed in compliance with the Quality Management System and applicable regulatory requirements, playing a critical role in maintaining a compliant validated state.

Key Responsibilities

• 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.

Qualifications & Experience

• 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.
• Certified Quality Engineer (CQE) or equivalent professional certification is an advantage.