Validation Lead

Eirdata; Dublin; On-site; EUR 85,000 - 130,000; Full time

Job summary

Eirdata, established in 2001, specializes in cleanroom validation, commissioning and compliance for pharma, medical devices and healthcare sectors. The Validation Lead will head the validation team delivering GMP validation projects, combining technical leadership with people management to ensure safe, on-time, compliant delivery.

You will mentor engineers, oversee project execution, drive improvements, cooperate with QA, Engineering and Manufacturing, and support business growth through

Qualifications

• Relevant engineering qualification (Level 7/8) in mechanical/building services.
• Trade background with mechanical/electrical HVAC experience welcome.
• 5–8 years hands-on GMP validation, commissioning or HVAC experience.

Responsibilities

• Develop, manage and execute validation plans, IQ/OQ/PQ reports in line with regulatory standards.
• Lead validation and commissioning of GMP HVAC systems, cleanrooms, laboratory equipment, LEVs, fume cupboards and utilities.
• Collaborate with QA, Engineering and Manufacturing to define validation requirements.
• Ensure compliance with EU GMP Annex 1, ISO 14644, EN 12469, EN 14175 and ALCOA+ principles.
• Conduct validation follow-ups to close actions and non-conformances promptly.
• Lead and coordinate validation team; conduct performance reviews and mentoring.
• Support quotations, tender submissions and business development opportunities.
• Manage validation project timelines, budgets and resources; support audits and records.
• Drive continuous improvement for efficiency, compliance and customer satisfaction.

Skills

EU GMP Annex 1

ISO 14644

Project management

Communication skills

Technical report writing

Problem solving

MS Office

Leadership

Mentoring

Commercial awareness

Full driving licence

Eligible to work in Ireland

Education

Level 7/8 Mechanical or Building Services Engineering degree

Trade background with HVAC experience

Job description

Established in 2001, Eirdata are specialists in cleanroom validation, commissioning & compliance. We provide these range of services to the pharmaceutical, medical devices and healthcare sectors primarily. In 2013, Eirdata was acquired by ESS Group. ESS Group is a multi-disciplinary engineering services organisation comprising of ESS, Eirdata, Critical Airflow, Predictive Maintenance, and PREMA.

Summary of the Role

The Validation Lead is responsible for leading the validation team in the delivery of GMP validation, commissioning and compliance projects across the pharmaceutical, medical device and healthcare sectors.

The role combines technical leadership with people management, ensuring projects are delivered safely, on time, within budget and to the highest quality standards while maintaining compliance with regulatory and customer requirements. The Validation Lead will mentor and develop engineers, provide technical guidance, oversee project execution, and drive continuous improvement across the validation function. Working closely with the Regional Manager and HVAC Validation Manager the role will support business growth through technical excellence, operational efficiency and outstanding customer service.

Duties & Main Responsibilities

Technical

• Develop, manage and execute validation plans, protocols (IQ, OQ, PQ) and reports in compliance with regulatory and industry standards.
• Lead validation and commissioning of GMP HVAC systems, cleanrooms, laboratory equipment, LEVs, fume cupboards and utilities.
• Collaborate with client cross-functional teams (e.g. Quality Assurance, Engineering and Manufacturing) to define and execute validation requirements.
• Ensure compliance with EU GMP Annex 1, ISO 14644, EN 12469, EN 14175 and ALCOA+ principles.
• Conduct validation follow-ups to ensure all identified actions and non-conformances are closed in a timely and compliant manner.

Leadership

• Lead and coordinate the validation team in the planning and execution of validation activities.
• Conduct annual performance reviews and regular one-to-one meetings with Validation Engineers and Graduate Engineers.
• Identify training and development requirements and support employee competency programmes.

Business

• Support quotations, tender submissions and business development opportunities.
• Manage validation project timelines, budgets and resources effectively.
• Support internal and external audits and maintain validation and calibration records.
• Drive continuous improvement initiatives to enhance efficiency, compliance and customer satisfaction.

Health, Safety & Quality

• Ensure all activities are carried out in accordance with Eirdata Health & Safety policies and customer site requirements.
• Promote a positive safety culture and ensure all team members comply with company procedures.
• Ensure all validation activities are completed in accordance with GMP, company procedures and Good Documentation Practice

Education & Qualifications

• Relevant engineering qualification, i.e. Level 7 or Level 8 Mechanical or Building Services Engineering degree, combined with practical hands-on experience.
• Candidates with a trade background (Mechanical/Electrical) and technician-level experience working with HVAC and utility systems will also be considered.
• 5-8 years hands-on experience with GMP Validation, Commissioning or HVAC Systems.

Required Skills

• Excellent understanding of EU GMP Annex 1 and ISO 14644 standards.
• Strong project management and organisational skills.
• Excellent communication and customer relationship skills.
• High standard of technical report writing.
• Strong problem-solving and decision-making ability.
• Working knowledge of Microsoft Office Suite.
• Ability to lead teams while maintaining a hands-on technical approach.
• Demonstrated leadership and mentoring skills.
• Commercial awareness with the ability to build and maintain strong customer relationships
• Full clean driving licence.
• Must be eligible to work in Ireland

Eirdata offer support that enables you to never stop growing. Your reward at Eirdata is not just your salary, we believe in investing in our people's personal, professional development and empowering their work-life balance to enable continuous growth.