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
Benefits
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.
-
Competitive Salary
-
Very attractive pension scheme
- VHI
-
Laptop
-
Mobile Phone
- Company Vehicle
-
Paid Annual Leave
-
Cont'd Education Program
