Validation Specialist

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

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call this a 3D Career, offering a supportive environment where you can grow, contribute and make a meaningful difference.

Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.

The Role

We are looking for a Validation Specialist to join our Validation and Quality team.

In this role, you will provide technical expertise and operational support across validation activities, helping maintain regulatory compliance, inspection readiness and continuous improvement. You will plan, coordinate and deliver qualification, validation, revalidation and periodic review activities across equipment, facilities, utilities, processes, cleaning validation, analytical methods and computerised systems.

Key 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 and experience required

• 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.
• Effective data analysis, reporting and documentation skills.
• Confidence using Microsoft Office applications.
• Experience supervising or mentoring junior colleagues would be advantageous.

How you will work

You will bring accountability, sound judgement and a collaborative approach. You will be comfortable solving problems, analysing information, raising issues appropriately and taking ownership of high-quality outcomes. A commitment to integrity, teamwork and continuous improvement will be important to success in this role.

Why join us?

At Norgine, you will be part of an inclusive environment where diverse perspectives are valued. You will have opportunities to develop your career while contributing to work that makes a meaningful impact on patients’ lives. We value people who are curious, reflective, collaborative and comfortable working independently while asking questions when needed.

Benefits may vary by location, and further information is available from the Norgine Talent Acquisition representative.

If you want to Dare, Drive and Develop through a multi-dimensional 3D Career, join us.

This advert summarises the main responsibilities of the role and is not exhaustive. Norgine may adjust responsibilities to meet business and organisational needs

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.

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