MSAT Single-Use Systems and Extractables & Leachables Specialist
Overview
GSK Barnard Castle site SME for SUS and E&L is a critical role focused on ensuring best practices and compliance with global technical standards. Acting as a site expert, they support consistent adoption and implementation of technical standards defined by global MSAT teams. The SME will work within a matrix environment, collaborating across sites and participating in Communities of Practice (CoPs) and task forces alongside global MSAT Standard SMEs. By facilitating knowledge sharing, driving performance improvements, and enabling alignment with regulatory and industry expectations, the SME plays a key role in advancing sterile manufacturing capabilities at the site level.
Responsibilities
* Serve as the main technical expert for SUS and E&L, responsible for material selection, system design, and sterility assurance. Conduct risk assessments to address E&L hazards across processes and materials, while evaluating new technologies to enhance manufacturing safety and efficiency.
* Define and roll out GSC technical standards and associated tools/templates. Support adoption of standards through coaching and mentorship. Establish governance frameworks to oversee compliant and improved delivery at site levels.
* Foster capability-building by mentoring site MSAT teams in SUS/E&L best practices and practical problem-solving. Provide technical training on emerging regulatory requirements and evaluate readiness for implementing new technologies.
* Participate in Communities of Practice and global initiatives to drive standardization and innovation. Lead improvement programs that enhance manufacturing efficiency and compliance. Define and track KPIs for standard implementation.
* Stay updated on regulatory guidance and global inspection trends related to SUS and E&L. Enable the implementation of best practices to meet international manufacturing requirements (e.g., FDA, EU GMP Annex 1).
* Collaborate with global MSAT leaders and site SMEs to align site operations with global standards and support GSC initiatives.
* Lead risk assessments for E&L, including extractables testing and leachables profiling for product contact materials and equipment. Oversee contamination control strategies and verify integrity of components such as filters, bags, and tubing.
Qualifications
* Bachelor’s/Master’s in Chemical Engineering, Pharmaceutical Sciences, or relevant fields.
* Extensive experience in relevant technical standards with proven application in areas such as E&L and SUS.
* Experience working with multidisciplinary teams.
* Risk Management/Project Management experience (qualification preferred, e.g., PRINCE2, PMP).
* Regulatory knowledge related to the specific expertise.
* Strong technical writing and communication skills.
* Autonomous, proactive, capable of influencing across levels; experience leading improvement activities in a matrix environment; ability to plan, organize and deliver to deadlines.
Why GSK
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, national origin, age, disability, genetic information, military service or any basis prohibited by law. We believe in an agile working culture and offer flexible opportunities. For adjustments in our process, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391.
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