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Permanent

MSAT Extractables and Leachables Specialist

Barnard Castle
money-bag 10000-500000 Annual
3034319105
Posted 6 days ago

MSAT Single-Use Systems and Extractables and Leachables SpecialistJob DetailsLocation: UK - County Durham - Barnard CastleCompetitive Salary and BonusesFull Time, Permanent PositionFully on site roleRole OverviewThe Site SME for Single-Use Systems (SUS) and Extractables and Leachables (EandL) ensures best practices and compliance with global technical standards. This role acts as a technical expert, supports adoption of global MSAT standards, collaborates across sites, and participates in Communities of Practice (CoPs). Drives performance improvements and regulatory alignment.Indirect reporting line to Global MSAT Business Process, Standards and External Manufacturing.Key ResponsibilitiesTechnical LeadershipServe as main technical expert for SUS and EandL. Material selection, system design, sterility assurance. Conduct risk assessments for EandL hazards. Evaluate new technologies for safety and efficiency.Standards Development and ImplementationDefine and roll out GSC technical standards and tools/templates. Coach and mentor for adoption of standards. Establish governance frameworks for compliance projects.Site Capability DevelopmentMentor MSAT teams in SUS/EandL best practices. Provide technical training on regulatory requirements. Assess readiness for new technologies.Continuous Improvement and CollaborationParticipate in CoPs and global initiatives. Lead improvement programs for efficiency and compliance. Define and track KPIs for technical standard implementation.Regulato

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