Sterile Processing and Facility Design Microbiological Technical Expert

**Site Name**: UK - County Durham - Barnard Castle
**Posted Date**: Apr 23 2025

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.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Join our dynamic team at GSK's Barnard Castle site where we are committed to maintaining and advancing sterile processing and facility design standards that not only meet but exceed regulatory requirements and GSK's high expectations. Collaborate with our Global Sterility Assurance team to influence and champion industry-leading practices, ensuring that our operations remain at the forefront of pharmaceutical excellence. Be a part of our mission to deliver the highest quality products and make a meaningful impact in the world of healthcare.
- In this role you will _
- Ensure site sterile processing standards and facility design are integrated into the site strategy and key project plans to maintain compliance with current and future regulatory standards and GSK QMS requirements.
- Collaborate with the Global Sterility Assurance team, participating in external activities to bring back industry best practices and innovations to the site.
- Train and mentor site personnel across departments to maintain and strengthen sterile manufacturing capabilities.
- Participate in key deviation investigations, change control reviews, and laboratory investigations requiring high-level sterile manufacturing technical expertise.
- Provide innovative solutions to enhance operational simplification, robustness, and efficiency in sterile manufacturing.
- Represent the site in updates to QMS policies, processes, and technical standards, and lead sterile manufacturing topics during site regulatory inspections.
- Why you?_

Basic Qualifications & Skills:

- Educated to Degree level i.e. BSc in a science / pharmaceutical quality related discipline
- GMP Pharmaceutical manufacture experience with understanding of data integrity, validation, regulatory inspection, deviation and change control processes
- Broad experience in sterile manufacture and testing activities, with demonstrated expertise in contamination control sterility assurance risk assessment, execution of facility qualification including aseptic process simulations and critical facility fault finding
- Exposure to senior management with ability to communicate technical risks clearly and coherently to enable understanding
- In-depth knowledge and understanding of principle regulatory standards (US, EU, Japan, PIC/S) applicable to sterile manufacture

Preferred Qualifications & Skills:

- Masters degree in a science / pharmaceutical quality related discipline
- Qualified Person Status
- Lead Auditor qualification
- Closing Date for Applications:_ 7th May 2025 (COB)_

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

**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).

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.

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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