MSAT Extractables & Leachables Specialist

SRG; Barnard Castle; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global pharmaceutical company in Barnard Castle seeks a Specialist for MSAT Single-Use Systems and Extractables & Leachables. In this role, you will drive performance improvements, ensure regulatory compliance, and mentor teams on best practices. The ideal candidate has a degree in Chemical Engineering and significant experience in E&L and SUS. This full-time, on-site position offers competitive salary and bonuses.

Benefits

Competitive Salary

Bonuses

Qualifications

• Extensive experience in E&L and/or SUS.
• Strong technical writing and communication skills.
• Risk Management/Project Management (Prince 2, PMP preferred).

Responsibilities

• Serve as main technical expert for SUS and E&L.
• Define and roll out GSC technical standards.
• Lead risk assessments for E&L hazards.

Skills

Experience in E&L and/or SUS

Regulatory knowledge

Strong technical writing skills

Risk Management/Project Management

Multidisciplinary team experience

Education

Bachelor's/Master's in Chemical Engineering

Job description

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.

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).

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)

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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.