Sterile Processing and Facility Design Microbiological Technical Expert

勤務地: UK - County Durham - Barnard Castle

公開日: 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 practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

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…

1. 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.

2. Collaborate with the Global Sterility Assurance team, participating in external activities to bring back industry best practices and innovations to the site.

3. Train and mentor site personnel across departments to maintain and strengthen sterile manufacturing capabilities.

4. Participate in key deviation investigations, change control reviews, and laboratory investigations requiring high-level sterile manufacturing technical expertise.

5. Provide innovative solutions to enhance operational simplification, robustness, and efficiency in sterile manufacturing.

6. 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:

1. Educated to Degree level i.e. BSc in a science / pharmaceutical quality related discipline

2. GMP Pharmaceutical manufacture experience with understanding of data integrity, validation, regulatory inspection, deviation and change control processes

3. 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

4. Exposure to senior management with ability to communicate technical risks clearly and coherently to enable understanding

5. In-depth knowledge and understanding of principle regulatory standards (US, EU, Japan, PIC/S) applicable to sterile manufacture

Preferred Qualifications & Skills:

1. Masters degree in a science / pharmaceutical quality related discipline

2. Qualified Person Status

3. 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.

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.