MSAT Product Lifecycle Management (CPV & Validation) Specialist

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.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

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The job owner is the site specialist for the following Technical Standard: Product Lifecycle Management PLM (Stage 1-Stage 3). This job aims at providing site expertise on the technical standards defined by the global teams. This

expertise is transferred through coaching, learning and guidance. The role will work in a matrix environment and through participating in the Community of Practice(s)/Task Force(s), with representation from the various GSC sites and global MSAT Standard SMEs, share good practice and work in the effective implementation of the technical standards at site.

In this role you will…

Technical Support

• The PLM SME mentors site teams, sharing expertise to build competence in MSAT technical standards. They provide hands-on support, guide problem-solving, and instil best practices to enable teams to independently manage lifecycle processes while optimizing operational performance. They provide technical oversight and direct cross-functional influence as required.

Development and Implementation of MSAT Standards

• The SME leads efforts to integrate global MSAT standards into site-level PLM processes across all stages. At Stage 1, focus is placed on tools and templates that aid technology transfer and process validation, ensuring readiness for clinical or commercial launch. In Stage 2, they support commercial scalability via monitoring systems and standardized workflows that maintain control over routine manufacturing. For Stage 3, tools are created to facilitate product optimization, sustainability assessments, or retirement plans, ensuring alignment with broader organizational goals.

Continuous Improvement and Community Engagement

• Participating in Communities of Practice (CoPs), the SME represents the site to share and adopt best practices globally. They lead improvement programs, monitor KPIs to identify gaps, and implement initiatives enhancing adherence, efficiency, and process robustness.

Governance and Issue Resolution

• The SME establishes governance frameworks and is responsible for the effective implementation of MSAT standards and improvement projects. They identify risks and challenges during implementation, escalating unresolved issues to prevent setbacks and drive proactive resolution.

Collaboration with Global MSAT Teams

• The SME partners with global MSAT Standards Leads and site SMEs to align site-specific practices with broader global strategies. They share insights to contribute to global projects, ensuring both site and strategic objectives are met efficiently.

Why You?

Basic Qualifications & Skills:

• University Degree in scientific discipline e.g. Scientific, Technical or Engineering with knowledge & experience on one of the following areas - validation life cycle for cleaning, product and process, contamination control, visual inspection or single use systems
• Experience of technical standards with proven application and delivery in one or more of the following areas: Product Lifecycle Management PLM (Stage 1-Stage 3)
• Previous experience of working with multidisciplinary teams
• Regulatory knowledge related to the specific expertise
• Strong technical writing and communication skills

Preferred Qualifications & Skills:

• Risk Management/ Project Management experience (qualification preferred e.g. Prince 2, PMP)
• Autonomous, proactive, with a positive and constructive attitude
• Ability to negotiate and influence a wide range of staff at different levels of the site and in different discipline areas
• Evidence of leading improvement activities in a matrix environment
• Ability to plan, organize and control workloads to meet deadlines and deliver schedule targets
• Ability to multi-task and work accurately under pressure

Closing Date for Applications: 10th October (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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.

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