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. 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 Responsibilities
Technical Leadership
Serve 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 & Implementation
Define and roll out GSC technical standards and tools/templates. Coach and mentor for adoption of standards. Establish governance frameworks for compliance projects.
Site Capability Development
Mentor MSAT teams in SUS/E&L best practices. Provide technical training on regulatory requirements. Assess readiness for new technologies. Participate in CoPs and global initiatives. Lead improvement programs for efficiency and compliance. Define and track KPIs for technical standard implementation.
Regulatory Awareness & Compliance
Stay updated on regulatory guidance (FDA, EU GMP Annex 1). Implement best practices for compliance. Align site operations with global standards. Support GSC initiatives for improvement and innovation. Lead 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
* 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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research and Science
Industry
Pharmaceutical Manufacturing
#J-18808-Ljbffr