Validation Engineer

Role Overview:

We are seeking an experienced Senior Validation Engineer to support a brownfield pharmaceutical facility project, with a dual focus on validation strategy and execution as well as close collaboration with the Commissioning & Qualification (C&Q) team. The successful candidate will play a key role in ensuring GMP compliance and readiness of equipment, systems, and processes, while also leading and executing temperature mapping and other critical validation activities.

Key Responsibilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for process equipment, utilities, and support systems.
• Lead and coordinate temperature mapping of warehouses, cold rooms, fridges, freezers, and controlled-temperature units using data loggers or Kaye Validator systems.
• Support the C&Q team with commissioning readiness, review of FAT/SAT documentation, and walkdowns.
• Author and manage validation plans, summary reports, and risk assessments (FMEA, impact assessments).
• Ensure alignment between C&Q deliverables and validation requirements for seamless handover and GMP compliance.
• Collaborate with cross-functional teams including QA, Engineering, and Manufacturing to troubleshoot and resolve qualification issues.
• Participate in and support audits, inspections, and deviation investigations related to validation activities.
• Track and report validation progress, ensuring documentation is ALCOA+ compliant and audit-ready.

Requirements:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related field.
• Minimum 7 years’ experience in validation within GMP pharmaceutical environments, including brownfield or retrofit projects.
• Hands-on experience in temperature mapping, validation of clean utilities (HVAC, WFI, etc.), and production equipment.
• Strong understanding of C&Q lifecycle, regulatory requirements (FDA, EMA), and data integrity principles.
• Familiarity with validation systems such as Kaye Validator, Veeva, Kneat, or TrackWise is advantageous.
• Excellent communication, documentation, and stakeholder management skills.