MSAT Extractables

23 hours ago

Barnard Castle, United Kingdom SRG Full time

MSAT Single-Use Systems and Extractables & 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 & 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.Guidant,

  • MSAT Extractables

    2 weeks ago

    Barnard Castle, United Kingdom SRG Full time

    MSAT Single-Use Systems and Extractables & Leachables Specialist Job Details 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...

  • MSAT Extractables

    15 hours ago

    Barnard Castle, United Kingdom SRG Full time

    MSAT Single-Use Systems and Extractables & Leachables Specialist Job Details 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...

  • MSAT Extractables

    2 weeks ago

    Barnard Castle, United Kingdom SRG Full time

    MSAT Single-Use Systems and Extractables & Leachables Specialist Job Details 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...

  • MSAT Single-Use Systems and Extractables

    2 weeks ago

    Barnard Castle, United Kingdom SRG Full time

    MSAT 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....

  • MSAT Technical Standards Manager

    4 weeks ago

    Barnard Castle, United Kingdom SRG Full time

    Job Title: MSAT Technical Standards ManagerLocation: Barnard Castle (Onsite) Contract Type: PermanentAbout the RoleAs MSAT Technical Standards Manager, you will lead a team of specialists at Barnard Castle, ensuring consistent application of global technical standards across legacy products and new product introductions. Key focus areas include:Product...

  • MSAT Technical Standards Manager

    4 days ago

    Barnard Castle, United Kingdom SRG Full time

    Job Title: MSAT Technical Standards ManagerLocation: Barnard Castle (Onsite) Contract Type: PermanentAbout the RoleAs MSAT Technical Standards Manager, you will lead a team of specialists at Barnard Castle, ensuring consistent application of global technical standards across legacy products and new product introductions. Key focus areas include:Product...

  • MSAT Single-Use Systems and Extractables

    2 days ago

    Barnard Castle, United Kingdom GSK Full time

    Site Name:UK - County Durham - Barnard CastlePosted Date:Oct 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, and as a key supplier of some of GSK's blockbuster products, the site contributes revenues of...

  • MSAT Single-Use Systems and Extractables

    2 days ago

    Barnard Castle, United Kingdom GSK Full time

    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, and 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...

  • MSAT Technical Standards Manager

    3 weeks ago

    barnard castle, United Kingdom SRG Full time

    Job Title: MSAT Technical Standards Manager Location: Barnard Castle (Onsite) Contract Type: Permanent About the Role As MSAT Technical Standards Manager , you will lead a team of specialists at Barnard Castle, ensuring consistent application of global technical standards across legacy products and new product introductions. Key focus areas include: Product...

  • MSAT SUS

    2 weeks ago

    Barnard Castle, United Kingdom SRG Full time

    A pharmaceutical manufacturing company is seeking a MSAT Single-Use Systems and Extractables & Leachables Specialist in Barnard Castle. This full-time role involves providing technical leadership, developing standards, mentoring teams, and ensuring compliance. The ideal candidate will have a relevant degree, extensive experience in E&L and/or SUS, and...