Process Monitoring Team Manager
Location: GSK Barnard Castle, UK – County Durham – Barnard Castle
We are looking for an experienced Process Monitoring Team Manager to lead environmental monitoring, aseptic compliance, and batch release activities within our sterile manufacturing operations.
Responsibilities
* 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 escalated 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
7th November 2025 (COB)
Application Instructions
When applying, please use the cover letter in the online application to describe how you meet the competencies outlined above. Your CV and cover letter will be used to assess your application.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, military service, or any basis prohibited under federal, state or local law.
If you require adjustments to our process, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391.
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