Quality Validation and CSV Senior Specialist

GSK; Fir Tree; On-site; GBP 65,000 - 85,000; Full time

Job summary

GSK Barnard Castle seeks a Quality Validation and CSV Senior Specialist to lead validation activities for processes, facilities, equipment and simple computerised systems, with oversight of NPI and batch documentation. You will collaborate with cross-functional teams to ensure compliant, efficient validation and risk-based decision making.

The role focuses on risk-based QA across projects, supporting inspections and continuous improvement, with opportunities for growth in a state-of-the-art

Qualifications

• 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 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.

Responsibilities

• 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, risk-based quality decisions and communicate rationale to stakeholders.
• Support inspections, prepare evidence and close agreed actions.
• Drive improvements to validation processes, templates and tools to increase efficiency and compliance.

Skills

Quality Assurance

Validation

CSV

GMP

Documentation

Cross-functional collaboration

Education

Degree in science/engineering

Advanced degree (preferred)

Tools

GAMP principles

MES/automation systems

IT/automation validation

Job description

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

• 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.

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

• 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., Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Problem Solving, Project Management, Quality Assurance (QA), Risk Awareness, Technical Writing, Validation Processes

Quality Validation and CSV Senior Specialist

(1x Perm, 1x FTC/Secondment)

Closing Date: 9th November 2026 (COB)

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., Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at