MSAT Extractables & Leachables Specialist

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 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.

Continuous Improvement & Collaboration

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.

Collaboration & Global Project Delivery

Align site operations with global standards. Support GSC initiatives for improvement and innovation.

Risk Management & Operational Support

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

- 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.

Closing Date for Applications: 12th November (COB)

Please save a copy of this Job Description as it will not be available after closure.

Use your CV or cover letter to demonstrate how you meet the competencies outlined above.

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.