Quality Validation and CSV Senior Specialist

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases, and as a key supplier of some of GSK's blockbuster products, the site contributes revenues of ~$2Bn annually.

Position Summary You will lead and deliver Quality Assurance, New Product Introduction (NPI), Validation and Computerised Systems Validation (CSV) activities across projects and operations, working closely with project teams, engineering, IT and manufacturing to ensure systems, processes and products are implemented and maintained in a compliant and effective manner. You will plan, execute and document risk-based quality and validation activities, provide practical problem-solving expertise, and support teams to achieve project and operational objectives on time. We value clear communicators who make evidence-based decisions, foster collaboration and drive continuous improvement. This role offers significant opportunities for professional growth, the chance to make a measurable impact on patient supply, and the opportunity to help unite science, technology and talent to get ahead of disease together.

Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Plan, lead and execute validation activities for processes, facilities, equipment and simple computerised systems.
• Provide quality oversight for new product introduction, technical transfers and batch documentation.
• Prepare and maintain validation protocols, test scripts, final reports and supporting evidence.
• Make timely, documented, risk-based quality decisions and clearly communicate rationale to stakeholders.
• Support internal and external inspections, prepare evidence and close agreed actions.
• Drive improvements to validation processes, templates and tools to increase efficiency and compliance.

Why You?

Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Degree in a scientific, technical or engineering discipline, or equivalent relevant experience.
• Practical experience in validation or quality assurance in a regulated environment.
• Experience in computerised system validation or lifecycle activities for IT/automation systems.
• Working knowledge of good manufacturing practice (GMP) and quality management systems.
• Experience producing and reviewing validation and batch release documentation.
• Clear communication skills and ability to work effectively with cross-functional teams.

Preferred Qualification If you have the following characteristics, it would be a plus:

• Advanced degree in science, engineering or a related technical field.
• Experience applying GAMP principles and data integrity requirements.
• Proven experience supporting regulatory inspections and interactions.
• Track record delivering validation for MES, automation or laboratory systems.
• Strong risk assessment skills and experience documenting risk-based decisions.
• Experience driving continuous improvement and validation tooling.

Working pattern This role is a full time onsite role at Barnard Castle in the United Kingdom. On-site presence will be required for inspections, validations and technical transfer activities.

What we value We look for people who are curious, collaborative and accountable. We welcome different perspectives and aim to create an environment where everyone belongs. You will be supported to develop your skills and grow your career while helping deliver high quality products to patients.

How to apply If this role feels like the right step for you, please apply and tell us how your skills and experience match the responsibilities. We welcome applications from people at different stages of their career and from all backgrounds. We look forward to hearing from you.