Validation Specialist at norgine-2

Location: Hengoed, Wales
Type: Full-time
Level: not_specified
Posted: Aug 14, 2026

Description

Norgine is seeking a Validation Specialist to join their Validation and Quality team. The specialist will provide technical expertise and operational support for validation activities, ensuring regulatory compliance, inspection readiness, and continuous improvement. Responsibilities include planning and delivering qualification, validation, revalidation, and periodic review activities across various aspects like equipment, facilities, utilities, processes, cleaning validation, analytical methods, and computerized systems.

Required Skills

Scientific degree or engineering discipline
Experience in pharmaceutical manufacturing, medical devices, biologics or another regulated healthcare environment.
Practical validation experience involving equipment, facilities, utilities, processes, cleaning validation and/or computerised systems.
Strong knowledge of cGMP principles and relevant EU and FDA regulatory expectations.
Experience preparing validation plans, protocols, reports and procedures.
Experience conducting risk assessments and supporting regulatory inspections or audits.
Knowledge of quality assurance methodologies and risk management techniques.
Strong written and verbal communication skills.
Effective data analysis, reporting and documentation skills.
Confidence using Microsoft Office applications.

Additional Information

Minimum Education: A Scientific degree or engineering discipline.
Required Previous Experiences: Experience in pharmaceutical manufacturing, medical devices, biologics or another regulated healthcare environment.
Practical validation experience involving equipment, facilities, utilities, processes, cleaning validation and/or computerised systems.
Experience preparing validation plans, protocols, reports and procedures.
Experience conducting risk assessments and supporting regulatory inspections or audits.