Cleaning Validation and PCCE Specialist

GSK; Barnard Castle; Hybrid; GBP 40,000 - 80,000; Full time

Job description

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.

The role involves serving as the site specialist for key Technical Standards, including Cleaning Validation and Contamination Control, which encompasses microbial contamination, Physical Contamination Cause and Elimination (PCCE), and Extractables & Leachables (E&L). The primary objective of this position is to provide site expertise on these technical standards as defined by global teams. This expertise will be disseminated through coaching, learning, and guidance. The successful candidate will work within a matrix environment, participating in Community of Practice(s) and Task Force(s) alongside representatives from various GSK sites and global MSAT Standard SMEs. This collaborative effort aims to share best practices and ensure the effective implementation of technical standards at the site. Additionally, the role includes an indirect reporting line to the MSAT Business Process, Standards, and External Manufacturing organisation.

In this role you will…

• Provide comprehensive guidance and leadership to site teams, ensuring adherence to relevant technical standards while fostering their professional growth.
• Ensure appropriate site resources are made available to deliver site standards while developing and enhancing site capabilities through targeted training and skill development programs.
• Actively participate in Communities of Practice, spearheading improvement initiatives and driving continuous advancement in technical standards.
• Advocate for appropriate site governance structures to effectively implement, deliver, and oversee technical standards and related improvement projects, while addressing any issues that may arise during the process.
• Work in partnership with the various global MSAT Standards Leads and other site counterparts to deliver key GSC projects, continuous improvements, and initiatives within areas of expertise.
• Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative/new technologies, industry standards, and registered risks pertaining to the area of expertise.

Why you?

Basic Qualifications & Skills:

• University Degree in scientific discipline
• Working experience required in relevant technical standard with proven application and delivery in one or more of the following areas:
  • Cleaning Verification/Validation lifecycle
  • Contamination Control (PCCE, E&L, microbial)
• Previous experience of working with multidisciplinary teams
• Risk Management/ Project Management
• Regulatory knowledge related to the specific expertise
• Strong technical writing and communication skills

Preferred Qualifications & Skills:

• Masters degree in a relevant field (e.g., Engineering, Quality Management, Pharmaceutical Sciences).

Closing Date for Applications: 10th April 2025

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 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.