Global Validation Supervisor

Inova Group; Connacht; On-site; EUR 90,000 - 120,000; Full time

Job summary

Inova Group, on behalf of a global medical device manufacturer in Co. Mayo, seeks a Validation Supervisor to lead a site-based team of Validation Quality Engineers.

You will plan, coordinate and execute equipment and process validations to support new product introductions, change controls and strategic initiatives, ensuring alignment with the Quality Management System. The role requires collaboration with Design Assurance, Engineering and Quality, strong leadership, and a track record in

Qualifications

• Bachelor's degree in Engineering, Science or a related discipline or equivalent experience.
• Desirable: CQE or equivalent professional certification.

Responsibilities

• Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring and performance guidance.
• Plan and coordinate equipment, process and test method validations supporting new product development, change control and strategic initiatives.
• Ensure validation activities follow internal procedures, regulatory requirements and industry best practice.
• 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.
• Support compliance activities, including internal audits, inspections and CAPA processes.
• Identify and drive continuous improvement in validation processes, standard work and compliance practices.
• Communicate complex technical information clearly to diverse stakeholders, including senior leadership.
• Manage multiple priorities and deadlines in a fast-paced, regulated manufacturing environment.

Skills

Leadership

Coaching

Problem solving

Risk-based decision-making

Communication

Education

Bachelor's degree in Engineering, Science or related

Advanced degree (desirable)

Job description

One of our key clients, a global medical device manufacturer in Co. Mayo, requires a Validation Supervisor to lead a site-based team of Validation Quality Engineers. The role is accountable for the planning, coordination and execution of equipment and process validation in support of new product introductions, change control and strategic initiatives. You will partner closely with Design Assurance, Engineering, Manufacturing and Quality to make sure validation is carried out in line with the Quality Management System and regulatory requirements, and you will play a central part in keeping the site in a compliant validated state.

Key Responsibilities

• Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring and performance guidance.
• Plan and coordinate equipment, process and test method validations supporting new product development, change control and strategic initiatives.
• Ensure validation activities follow internal procedures, regulatory requirements and industry best practice.
• 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.
• Support compliance activities, including internal audits, inspections and CAPA processes.
• Identify and drive continuous improvement in validation processes, standard work and compliance practices.
• Communicate complex technical information clearly to diverse stakeholders, including senior leadership.
• Manage multiple priorities and deadlines in a fast-paced, regulated manufacturing environment.

Experience & Qualifications

• 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.
• Experience in medical device, pharmaceutical or similarly regulated manufacturing environments.
• Prior experience leading or supervising technical or quality teams (required).
• Strong problem-solving, critical thinking and risk-based decision-making skills.

Desirable

• Certified Quality Engineer (CQE) or equivalent professional certification.
• Advanced degree in a technical or scientific discipline.
• Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11 and related standards.
• Experience with statistical analysis and validation tools.
• Experience supporting audits and regulatory inspections.