Pharmaceutical Manufacturing
2 weeks ago
MSAT Single-Use Systems and Extractables & Leachables SpecialistLocation: UK – County Durham – Barnard CastleCompetitive Salary and Bonuses Full Time, Permanent Position Fully on site roleRole OverviewThe Site SME for Single-Use Systems (SUS) and Extractables & Leachables (E&L) 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 E&L. Material selection, system design, sterility assurance. Conduct risk assessments for E&L hazards. Evaluate new technologies for safety and efficiency.Standards Development & 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/E&L best practices. Provide technical training on regulatory requirements. Assess readiness for new technologies.Continuous Improvement & CollaborationParticipate in CoPs and global initiatives. Lead improvement programs for efficiency and compliance. Define and track KPIs for technical standard implementation.Regulatory Awareness & ComplianceStay updated on regulatory guidance (FDA, EU GMP Annex 1). Implement best practices for compliance.Collaboration & Global Project DeliveryAlign site operations with global standards. Support GSC initiatives for improvement and innovation.Risk Management & Operational SupportLead risk assessments for E&L hazards. Oversee extractables testing and leachables profiling. Verify operational integrity of components (filters, media bags, tubing).Why You?Basic Qualifications & Skills- Bachelor's/Master's in Chemical Engineering, Pharmaceutical Sciences, or related fields.- Extensive experience in E&L and/or SUS.- Multidisciplinary team experience.- Risk Management/Project Management (Prince 2, PMP preferred).- Regulatory knowledge.- Strong technical writing and communication skills.Preferred Qualifications & Skills- Autonomous, proactive, positive attitude.- Negotiation and influencing skills.- Experience leading improvement activities in a matrix environment.- Strong planning and organizational skills.- Ability to multi-task and work under pressure.
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Pharmaceutical Manufacturing
2 weeks ago
Barnard Castle, United Kingdom SRG Full timeMSAT Single-Use Systems and Extractables & Leachables SpecialistLocation: UK – County Durham – Barnard CastleCompetitive Salary and Bonuses Full Time, Permanent Position Fully on site roleRole OverviewThe Site SME for Single-Use Systems (SUS) and Extractables & Leachables (E&L) ensures best practices and compliance with global technical standards. This...
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Pharmaceutical Manufacturing
7 days ago
Barnard Castle, United Kingdom SRG Full timeMSAT Single-Use Systems and Extractables & Leachables SpecialistLocation: UK – County Durham – Barnard CastleCompetitive Salary and Bonuses Full Time, Permanent Position Fully on site roleRole OverviewThe Site SME for Single-Use Systems (SUS) and Extractables & Leachables (E&L) ensures best practices and compliance with global technical standards. This...
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Pharmaceutical Manufacturing
6 days ago
Barnard Castle, County Durham, United Kingdom SRG Full timeMSAT Single-Use Systems and Extractables & Leachables Specialist Location: UK – County Durham – Barnard Castle Competitive Salary and Bonuses Full Time, Permanent Position Fully on site role Role Overview The Site SME for Single-Use Systems (SUS) and Extractables & Leachables (E&L) ensures best practices and compliance with global technical standards....
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Pharmaceutical Manufacturing
6 days ago
Barnard Castle, County Durham, United Kingdom SRG Full timeMSAT Single-Use Systems and Extractables & Leachables Specialist Location: UK – County Durham – Barnard Castle Competitive Salary and Bonuses Full Time, Permanent Position Fully on site role Role Overview The Site SME for Single-Use Systems (SUS) and Extractables & Leachables (E&L) ensures best practices and compliance with global technical standards....
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Senior Automation Lead – Pharma Manufacturing
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Barnard Castle, United Kingdom GSK Full timeA leading pharmaceutical company is seeking a Senior Director for New Product Introduction Operational Readiness. In this role, you will lead operational readiness efforts across manufacturing and supply teams, oversee capital investment, and ensure timely product startup. The ideal candidate has at least 5 years of relevant experience in the pharmaceutical...
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