Validation Specialist

Your new company
Join a global leader in the diagnostics space with 40+ years of experience delivering innovative solutions that improve patient outcomes. With cutting-edge manufacturing facilities across the UK, US, and Canada, this organisation provides intelligent diagnostic systems, reagents, and raw materials to healthcare professionals, labs, and pharmaceutical partners worldwide. Their culture is built on integrity, innovation, and inclusion-offering a collaborative environment where your work directly contributes to advancing global health.

Your new role

• Leading validation activities for laboratory and manufacturing systems in alignment with GMP and global quality standards
• Designing and executing validation protocols for equipment, facilities, and cleaning processes, ensuring scientific rigour and compliance
• Developing and maintaining critical documentation such as SOPs, Validation Master Plans, and technical reports
• Conducting environmental monitoring activities, including temperature mapping of controlled storage units
• Managing the lifecycle of validated systems through proactive scheduling and risk-based assessments
• Collaborating with cross-functional teams including QA, Engineering, and Lab Operations to drive quality outcomes
• Keeping informed of regulatory changes and translating them into actionable updates for internal stakeholders
• Supporting audit readiness and participating in inspections by regulatory bodies and clients

What you'll need to succeed

• A degree in a relevant scientific or technical field (e.g., life sciences, chemistry, engineering)
• Minimum of 5 years' experience in validation or a closely related quality role within a regulated environment
• Strong working knowledge of EudraLex Volume 4, particularly Annex 11 & 15, and their application in validation activities
• Familiarity with ISO 9001 and ISO 13485 quality management systems
• Practical experience with validation lifecycle stages including IQ, OQ, PQ, and PV, as well as temperature mapping techniques
• Skilled in drafting and reviewing validation documentation such as protocols, reports, and SOPs
• Solid understanding of calibration principles and compliance systems

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.