Validation & Compliance Specialist

Norgine; Hengoed; On-site; GBP 38,000 - 52,000; Full time

Job summary

Norgine in the United Kingdom is seeking a Validation Specialist to join the Validation and Quality team. You will provide technical expertise and coordinate qualification, validation, revalidation and periodic review activities across equipment, facilities, utilities, processes, cleaning validation and computerised systems.

The role emphasizes regulatory compliance (GMP, EU and FDA), cross-functional collaboration and continuous improvement; you will plan, review plans and reports, monitor

Qualifications

• Scientific degree or engineering discipline.
• Experience in regulated healthcare environments (pharma, devices or biologics).
• Practical validation experience with equipment, facilities, utilities, processes and validated systems.
• Strong knowledge of cGMP principles and EU/FDA regulatory expectations.
• Experience preparing validation plans, protocols, reports and procedures.
• Strong written and verbal communication skills.
• Experience supervising or mentoring junior colleagues would be advantageous.

Responsibilities

• Plan and deliver qualification, validation, revalidation and periodic review activities in line with site strategies and regulatory requirements.
• Prepare, review and maintain validation plans, protocols, reports, schedules and procedures.
• Maintain compliant validation activities and records throughout the validation lifecycle.
• Support cross-functional projects, risk assessments, change controls and validation impact assessments.
• Provide validation guidance and support compliance with GMP, EU and FDA requirements.
• Act as a Validation Subject Matter Expert when required.
• Support investigations, CAPAs, audits, complaints and other quality events.
• Monitor trends and risks, produce validation metrics, deliver training and contribute to continuous improvement.
• Collaborate with site and global stakeholders to achieve validation objectives.

Skills

Strong communication

Data analysis

Documentation skills

Microsoft Office

Mentoring

Education

Scientific degree or engineering

Tools

Microsoft Office

Job description

Norgine in the United Kingdom is seeking a Validation Specialist to join the Validation and Quality team. You will provide technical expertise and coordinate qualification, validation, revalidation and periodic review activities across equipment, facilities, utilities, processes, cleaning validation and computerised systems.

The role emphasizes regulatory compliance (GMP, EU and FDA), cross-functional collaboration and continuous improvement; you will plan, review plans and reports, monitor