Validation Engineer - IQ/OQ/PQ & Thermal (Hybrid)

Cpl Group; Ireland; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

Cpl Group is seeking a Validation Engineer (IQ/OQ/PQ & Thermal Validation) to lead qualification activities in GMP manufacturing environments across Ireland, UK and Europe.

The role involves developing and executing IQ/OQ/PQ protocols, conducting thermal mapping, and providing regulatory-compliant validation deliverables. Collaboration with Engineering, Quality and Production teams is essential to maintain GMP, FDA and EU standards.

Qualifications

• Degree qualification in Engineering, Science, Biotechnology or related discipline.
• Strong experience executing IQ, OQ, PQ and thermal validation in pharma/biopharma environments.
• Good understanding of GMP regulations and validation lifecycle.

Responsibilities

• Develop, execute and manage IQ, OQ and PQ protocols.
• Lead thermal mapping and thermal validation studies.
• Support validation strategy development and project planning.
• Execute qualification activities for autoclaves, sterilisers, depyrogenation ovens, controlled temperature storage, freezers and GMP utility systems.
• Review and analyse validation data.
• Investigate deviations and support CAPA implementation.
• Generate validation summary reports and final validation packages.
• Participate in customer audits and regulatory inspections.
• Collaborate with Engineering, Quality and Production teams.
• Ensure compliance with GMP, FDA and EU requirements.

Skills

IQ/OQ/PQ

Thermal validation

Data analysis

Technical writing

GMP knowledge

Education

Engineering/Science/Biotech degree

Tools

Kneat

E-Val Pro

Job description

Cpl Group is seeking a Validation Engineer (IQ/OQ/PQ & Thermal Validation) to lead qualification activities in GMP manufacturing environments across Ireland, UK and Europe.

The role involves developing and executing IQ/OQ/PQ protocols, conducting thermal mapping, and providing regulatory-compliant validation deliverables. Collaboration with Engineering, Quality and Production teams is essential to maintain GMP, FDA and EU standards.