Quality Validation and CSV Senior Specialist

Quality Validation and CSV Senior Specialist

(1x Perm, 1x FTC/Secondment)

Closing Date: 23rd September 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.

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.

Skills

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

 

 

Why GSK?

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.

 

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call.

 

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a  Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

 

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

 

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 https://openpaymentsdata.cms.gov/