Allegis Global Solutions
Computer System Validation Specialist
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Job Title: Computer System Validation Specialist
Location: GSK HQ, Stanley Building, London
Overview
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.
At GSK, we are actively working on building a future in which state-of-the-art software, Artificial Intelligence (AI) and Machine Learning (ML) enable us to develop new therapies and personalized medicines that drive better outcomes for patients at reduced cost with fewer side effects. This ambitious mission requires scalable, cloud-native solutions at the forefront of Software Engineering, Cloud Infrastructure, Efficient Compute, Machine Learning and AI. If this excites you, we would love to chat.
Role Overview
As part of GSK’s ambition to “Supercharge our data capability”, the Onyx Research Data Platform organization represents a major investment by GSK R&D and Digital & Tech, designed to deliver a step-change in our ability to leverage data, knowledge, and prediction to find new medicines. We are a full-stack shop consisting of product and portfolio leadership, data engineering, infrastructure and DevOps, data / metadata / knowledge platforms, and AI/ML and analysis platforms, all geared toward:
- Building a next-generation, metadata- and automation-driven data experience for GSK’s scientists, engineers, and decision-makers, increasing productivity and reducing time spent on “data mechanics”.
- Providing best-in-class AI/ML and data analysis environments to accelerate our predictive capabilities and attract top-tier talent.
- Aggressively engineering our data at scale, as one unified asset, to unlock the value of our unique collection of data and predictions in real-time.
We are looking for a high performing and enthusiastic Computer System Validation Specialist who will work with stakeholders to drive the Onyx Quality agenda forward at pace.
Key Responsibilities
- Write and maintain validation documentation in a timely manner — under guidance from the Assurance Lead, following GSK templates and SOPs.
- As required, execute test scripts against approved protocols, accurately recording results, screenshots, and evidence to support GxP compliance.
- Document deviations, discrepancies, and non-conformances observed during testing, escalating to senior team members for review and resolution.
- Support change control activities by drafting impact assessments and updating validation documentation when systems are modified, patched, or upgraded.
- Maintain accurate and audit-ready validation records/files, ensuring documentation is organized, version-controlled, and readily retrievable.
- Assist with periodic reviews of validated systems, helping track requalification schedules and flagging systems approaching review dates.
- Under guidance from the Assurance Lead, coordinate with system owners and other members of Tech and R&D to gather information needed for validation documentation (e.g., configuration details, requirements, test evidence).
- Support audit and inspection readiness by helping compile documentation packages and locating requested records.
- Follow established validation methodology and risk classification frameworks (rather than defining them), applying senior-approved risk assessments to scope testing appropriately.
- Build foundational knowledge of GxP regulations (21 CFR Part 11, Annex 11) and GSK SOPs, escalating any compliance questions rather than making independent judgment calls on ambiguous cases.
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Skills & Experience Required
- 5+ years of relevant project management and business analysis experience, preferably within software environments.
- Sound knowledge of the software development lifecycle and Agile methodology is desirable.
- Working knowledge of electronic systems and tools such as Jira and Confluence is highly desirable.
- Excellent written and verbal communication skills, technical writing ability, and the ability to communicate using concise language.
- Proven ability to review and assess technical information, ensuring delivery of user-focused, fit-for-purpose, and simple content.
- Demonstrated ability to motivate and work collaboratively with a team of expert staff to deliver consistently high standards.
- Bachelor's degree or equivalent work experience.
- Master's degree or strong work experience in Computer System Validation is desirable.
- Flexible and adaptable according to the priorities and needs of the business.
- Global perspective and cultural sensitivity.
- Ability to work under pressure, self-motivated with a strong sense of urgency.
- Understands the basics of, or has experience working with, data engineering teams, GCP, and software platforms.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Inclusion at GSK
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
If you need any adjustments in the recruitment process, please get in touch with our Recruitment team (EMEA-GSKLink@allegisglobalsolutions.com) to further discuss this today.
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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 GSK’s Transparency Reporting For the Record site.
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