Validation & Facility Engineer

Hero Recruitment; Galway; On-site; EUR 60,000 - 80,000; Full time

Job summary

Hero Recruitment is seeking an experienced Validation Engineer / Facility Supervisor in Galway, Ireland. This role focuses on supporting the operational readiness, validation, and management of laboratory facilities. The successful candidate should have a strong background in laboratory validation and quality systems.

Responsibilities include leading validation activities, developing protocols, and coordinating maintenance. Applicants should possess a relevant degree and at least 5 years of experience in a regulated environment.

Qualifications

• Minimum of 5 years' experience in a regulated laboratory or pharmaceutical environment.
• Strong background in laboratory validation and quality systems.
• Knowledge of GMP, GLP, and regulated documentation requirements.

Responsibilities

• Lead validation activities for laboratory equipment and associated processes.
• Develop, execute and maintain validation protocols and documentation.
• Coordinate preventative maintenance and calibration schedules.

Skills

Laboratory validation

Equipment qualification

Quality systems

Analytical skills

Organisational skills

Problem-solving skills

Communication skills

Education

Degree in Engineering, Life Sciences or related discipline

Job description

Overview

We are seeking an experienced Validation Engineer / Facility Supervisor to support the operational readiness, validation and ongoing management of newly established laboratory facilities. This role will focus on laboratory validation, equipment qualification, quality systems, maintenance planning and documentation to ensure laboratories are fully operational, compliant and prepared for future certification.

Initially, the successful candidate will support the start-up and ongoing operation of two laboratories, with additional laboratories planned in the future. This is a hands-on role requiring strong experience in laboratory validation, regulated quality environments and laboratory operations.

Key Responsibilities

• Lead validation activities for laboratory equipment, utilities and associated processes, including IQ, OQ and PQ where applicable.
• Develop, execute and maintain validation protocols, reports and supporting documentation to meet GMP, GLP and company quality standards.
• Support laboratory operational readiness, including equipment qualification, environmental monitoring, utility validation and facility risk assessments.
• Develop, review and standardise laboratory procedures, SOPs, validation records and quality documentation, ensuring full traceability and document control.
• Support cleaning validation activities and maintain validation lifecycle documentation.
• Coordinate preventative maintenance, calibration and re-validation schedules for laboratory equipment and facilities.
• Support laboratory quality systems, including change control, deviations, investigations, supplier documentation and standards gap assessments.
• Assist with laboratory commissioning activities, equipment risk assessments, URS documentation and traceability matrices.
• Manage laboratory maintenance activities, validation records and documentation archiving while supporting laboratory budgets and external service providers.
• Work closely with Engineering, Facilities, Quality and EHS teams to ensure laboratories remain compliant, safe and inspection-ready.

Experience & Qualifications

• Degree in Engineering, Life Sciences or a related scientific discipline.
• Minimum of 5 years' experience in a regulated laboratory, pharmaceutical, biotechnology or medical device environment.
• Strong background in laboratory validation, equipment qualification and quality systems.
• Experience with facility, utility and equipment validation, including risk assessments and validation lifecycle principles.
• Knowledge of GMP, GLP and regulated documentation requirements, including ISO 41001.
• Experience managing laboratory maintenance, calibration and preventative maintenance programmes would be advantageous.
• Strong analytical, organisational and problem-solving skills.
• Excellent communication skills with the ability to work across cross-functional teams.

Desirable Experience

• Experience supporting laboratory commissioning or start-up projects.
• Familiarity with laboratory certification or accreditation processes.
• Experience supervising laboratory operations, facilities or validation activities.
• Knowledge of environmental monitoring systems (e.g. Vaisala) and laboratory utility management.

Working Pattern

Four days onsite, one day remote.