Validation Engineer

Hanley Calibration; Leinster; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Professional development opportunities

Job summary

Hanley Calibration in Dublin, Dun Laoghaire, is seeking a Validation Engineer to join our team supporting a long-standing partnership with a global biopharmaceutical leader. You will validate capital projects and routine activities in a highly regulated environment, ensuring GMP compliance and quality standards.

You will apply expertise in CTC validation, perform thermal mappings, and contribute to SOPs, URS, and risk assessments while collaborating with cross-functional teams to drive

Qualifications

• Bachelor's degree in Science or Engineering is required.
• Knowledge of cGMP and regulatory requirements.
• Strong problem-solving with excellent written and verbal communication.
• Proficiency in Microsoft Office; experience with Ellab thermal mapping systems and KNEAT software is desirable.
• Previous experience in the pharmaceutical industry is an advantage.

Responsibilities

• Provide technical expertise in Controlled Temperature Chambers (CTCs) to meet site objectives.
• Prepare, execute, and document validation protocols and reports in accordance with GMP and regulatory requirements.
• Perform thermal mapping executions for CTCs and manage periodic reviews and requalifications in line with the validation master plan.
• Develop and maintain Standard Operating Procedures (SOPs) to meet site and corporate requirements.
• Assist in creating User Requirement Specifications (URS) and Quality Risk Assessments for equipment and automated systems.
• Participate in cross-functional teams and contribute to investigations and continuous improvement initiatives.
• Ensure compliance with site safety requirements and champion safe working practices.

Skills

Problem-solving

Written and verbal communication

cGMP knowledge

Education

Bachelor's degree in Science or Engineering

Tools

MS Office

Ellab thermal mapping

KNEAT software

Job description

Validation Engineer - Hanley Calibration (Dublin, Dun Laoghaire)

Hanley Calibration is seeking a Validation Engineer to join our team supporting a long-standing partnership with a global biopharmaceutical leader. This role involves working on critical capital projects and routine activities within a highly regulated environment, ensuring compliance with GMP and quality standards.

Key Responsibilities

• Provide technical expertise in Controlled Temperature Chambers (CTCs) to meet site objectives.
• Prepare, execute, and document validation protocols and reports in accordance with GMP and regulatory requirements.
• Perform thermal mapping executions for CTCs and manage periodic reviews and requalifications in line with the validation master plan.
• Develop and maintain Standard Operating Procedures (SOPs) to meet site and corporate requirements.
• Assist in creating User Requirement Specifications (URS) and Quality Risk Assessments for equipment and automated systems.
• Participate in cross-functional teams and contribute to investigations and continuous improvement initiatives.
• Ensure compliance with site safety requirements and champion safe working practices.

Qualifications & Experience

• Bachelor's degree in Science or Engineering (or equivalent).
• Knowledge of cGMP and regulatory requirements.
• Strong problem-solving skills with excellent written and verbal communication.
• Proficiency in Microsoft Office; experience with Ellab thermal mapping systems and KNEAT software is desirable.
• Previous experience in the pharmaceutical industry is an advantage.

Why Hanley Calibration?

• Work on high-impact projects in collaboration with a world-class biopharmaceutical facility.
• Gain exposure to advanced technologies and industry best practices.
• Competitive salary, benefits, and opportunities for professional development.