Validation Specialist: Drive GMP Compliance & Impact

Internetwork Expert; Hengoed; On-site; GBP 40,000 - 60,000; Full time

Job summary

Norgine is seeking a Validation Specialist to join the Validation and Quality team in the UK. You will provide technical expertise across qualification, validation, revalidation and periodic reviews for equipment, facilities, utilities, processes, cleaning validation, analytical methods and computerised systems.

Role involves planning, coordinating and delivering validation activities, ensuring regulatory compliance (GMP, MHRA, EU and FDA), and supporting investigations, audits and continuous

Qualifications

• A 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.

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 applicable GMP, MHRA, 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

Scientific communication

Regulatory knowledge

Validation

Risk assessment

Data analysis

Microsoft Office

Team mentoring

Education

Scientific degree or engineering

Tools

MS Office

Job description

Norgine is seeking a Validation Specialist to join the Validation and Quality team in the UK. You will provide technical expertise across qualification, validation, revalidation and periodic reviews for equipment, facilities, utilities, processes, cleaning validation, analytical methods and computerised systems.

Role involves planning, coordinating and delivering validation activities, ensuring regulatory compliance (GMP, MHRA, EU and FDA), and supporting investigations, audits and continuous