CQV Engineer - SIP/Thermal Mapping

Overview PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of over 4,000+ people. We deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.

We are looking for an experienced Senior CQV / Thermal Validation Engineer is required to support a client project, with responsibility for SIP cycle development, Ellab thermal mapping and Performance Qualification activities across GMP process equipment.

Responsibilities

• Develop and optimise SIP cycles, including heat-up, exposure and cool-down parameters.
• Define worst-case locations and thermal mapping challenge conditions.
• Configure and deploy Ellab thermal validation equipment.
• Execute temperature distribution and heat penetration studies.
• Analyse thermal mapping data and identify cold spots.
• Author and execute cycle development and PQ protocols.
• Assess cycle repeatability and compliance with approved acceptance criteria.
• Prepare qualification reports and support deviation investigations.
• Coordinate activities with Engineering, Automation, Operations and Quality.

Qualifications

• Minimum five years of CQV or validation experience within pharmaceutical or biotechnology manufacturing.
• Proven hands-on experience in SIP cycle development and optimisation.
• Practical experience using Ellab equipment and associated software.
• Strong knowledge of thermal mapping, heat penetration and steam sterilisation.
• Experience authoring and executing PQ protocols and reports.
• Strong GMP documentation, data analysis and technical writing skills.

Desirable: Experience with biologics or sterile manufacturing, Kneat, DeltaV or Pfizer validation systems would be advantageous.

Why PM Group? As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our Corporate Responsibility and Heath, Safety & Well-being Report. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.