Validation Engineer IQ/OQ/PQ & Thermal Validation

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

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

Location

Ireland (Hybrid / Site-Based Travel Required)

Travel

Ireland, United Kingdom and Europe

About the Role

Our client, a leading life sciences engineering organisation, is seeking an experienced Validation Engineer to support qualification and validation projects within pharmaceutical and biopharmaceutical manufacturing environments.

The successful candidate will be responsible for the execution and management of IQ, OQ, PQ and Thermal Validation activities across a variety of GMP-regulated manufacturing systems, facilities and utility processes.

This position offers an excellent opportunity to work on high-profile pharmaceutical and biotechnology projects while contributing to regulatory compliance, operational excellence and manufacturing quality standards.

Key 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 areas
  • Freezers and cold rooms
  • 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 closely with Engineering, Quality and Production teams.
• Ensure compliance with GMP, FDA and EU regulatory requirements.

Requirements

• Degree qualification in Engineering, Science, Biotechnology or a related discipline.
• Strong validation experience within pharmaceutical or biopharmaceutical manufacturing environments.
• Demonstrated experience executing:
  • IQ
  • OQ
  • PQ
  • Thermal Mapping
  • Thermal Validation
• Strong understanding of GMP regulations and validation lifecycle principles.
• Experience managing deviations, investigations and change controls.
• Excellent technical writing and data analysis skills.
• Experience supporting regulatory compliance and validation documentation activities.

Desirable Experience

• CQV (Commissioning, Qualification & Validation) experience.
• Sterilisation validation.
• Clean utility validation.
• HVAC qualification.
• Temperature-controlled storage qualification.
• Experience using Kneat, E-Val Pro or equivalent validation software.
• Knowledge of statistical data analysis tools.
• Experience supporting audits and regulatory inspections.

Candidate Profile

The ideal candidate will be:

• Detail-oriented and compliance focused.
• Highly organised and capable of managing multiple projects.
• Comfortable reviewing large volumes of technical documentation.
• Experienced in technical report writing and data analysis.
• Effective in cross-functional team environments.
• Confident working with Quality, Engineering and Regulatory stakeholders.

What's on Offer

• Opportunity to work on high-profile pharmaceutical and biotechnology projects.
• Exposure to leading international manufacturing facilities.
• Involvement in complex GMP validation programmes.
• Ongoing professional development and specialist training.
• Long-term career progression within a growing life sciences engineering organisation.

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