Validation Engineer

Our client is a specialist consultancy providing expert services to the pharmaceutical, medical device, and food supplement industries across the full product lifecycle.

As the Validation Engineer, you will play a critical role in ensuring all validation and qualification activities meet regulatory, safety, and quality standards. You'll work closely with cross-functional teams, provide technical leadership, and help shape validation strategies across equipment, facilities, utilities, and control systems.

Responsibilities:

• Execute validation/qualification activities in line with cGMP, EU Annex 11 & 15, and company QMS.
• Author and report validation documentation (URS, IQ/OQ/PQ, Validation Summary Reports).
• Serve as subject matter expert for Computerised System Validation aligned with GAMP 5 and 21 CFR Part 11.
• Manage validation projects and coordinate between key stakeholders.
• Review maintenance histories, lead investigations, support audits, and improve processes.
• Provide technical input to equipment design and commissioning plans.
• Ensure compliance with engineering, safety, and quality standards.

Requirements:

• 5+ years of experience in a similar validation role within a pharmaceutical or GMP-regulated environment.
• Degree in Mechanical, Electrical, Chemical Engineering, or equivalent experience.
• Deep understanding of GMP, validation requirements, and regulatory expectations.
• Skilled in Change Control and development of Master Validation Plans.