Overview
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. 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.
Responsibilities
* The Process Monitoring Team Manager provides leadership in environmental monitoring, aseptic compliance, and batch release activities, ensuring sterile manufacturing operations.
* Manage and oversee routine environmental monitoring (viable and non-viable) in sterile manufacturing areas, ensuring compliance with regulatory and internal standards and driving operational efficiency.
* Ensure the timely execution of time-critical testing to support production schedules and minimise operational disruptions, aligning resources effectively.
* Provide leadership and oversight during sterile operations, ensuring compliance with aseptic techniques, cleanroom behaviours, and sterility assurance practices, and resolving complex issues.
* Identify, assess, and escalate deviations or incorrect practices in sterile operations, leading investigations and ensuring corrective and preventive actions are implemented to maintain compliance and product quality.
* Lead the development and delivery of training programmes to educate operators and production staff on aseptic principles and behaviours, fostering a culture of compliance and sterility assurance.
* Ensure the accuracy, completeness, and compliance of documentation for environmental monitoring and testing activities, adhering to all regulatory and internal standards.
* Review and analyse monitoring data to identify trends, anomalies, or risks, providing strategic recommendations to senior stakeholders and driving process improvements.
* Collaborate with production, quality, and engineering teams to ensure seamless execution of monitoring activities during critical manufacturing operations and provide sterility assurance input to batch release.
* Oversee the batch release process by reviewing environmental monitoring data and sterility assurance assessments to ensure compliance with regulatory standards.
* Manage and support project and routine requalification studies such as smoke pattern evaluations and biological indicator testing, ensuring sterility assurance requirements are met and validated.
Qualifications
* Science related degree
* Strong experience in production and laboratory environments.
* Strong knowledge of regulatory requirements (e.g., FDA, MHRA, EMA) and industry standards (e.g., cGMP, ISO).
* Excellent problem-solving skills and attention to detail.
* Strong leadership and project management abilities.
* Effective communication and interpersonal skills.
Closing Date for Applications: 7th November 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.
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.
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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