MSAT Single-Use Systems and Extractables & Leachables Specialist in Bath

MSAT Single-Use Systems and Extractables & Leachables SpecialistWe are currently looking for an MSAT Single-Use Systems and Extractables & Leachables (E&L) Specialist to join a leading biopharmaceutical manufacturing site based in Durham. This is an exciting opportunity for a technical expert to contribute to the advancement and compliance of sterile manufacturing processes at a key production facility supporting blockbuster products.

Key Duties And Responsibilities

Serve as the main technical expert for Single-Use Systems (SUS) and Extractables & Leachables (E&L), providing guidance on material selection, system design, and sterility assurance protocols.

Conduct risk assessments to identify and mitigate hazards associated with E&L, ensuring compliance with global regulatory standards.

Lead the development, rollout, and governance of technical standards, tools, and templates to ensure consistent application across the site.

Foster site capability through mentoring and technical training in SUS/E&L best practices, regulatory requirements, and new technology evaluations.

As the Site SME, support global projects and initiatives, collaborating with cross‐disciplinary teams to drive performance improvements and ensure alignment with industry standards.

Role Requirements

A Degree or higher level in Chemical Engineering, Pharmaceutical Sciences, or relevant fields.

Proven experience working with multidisciplinary teams, with expertise in E&L and Single‐Use Systems within a biopharmaceutical manufacturing setting.

Experience in risk management and project management (qualification such as Prince 2 or PMP is preferred).

Strong regulatory knowledge related to E&L, SUS, and sterile manufacturing standards.

Excellent technical writing and communication skills, with the ability to influence and negotiate across various disciplines.

WHAT\’S IN IT FOR YOU?

Competitive salary and annual bonus based on company performance.

Comprehensive healthcare and wellbeing programmes.

Pension plan membership.

Shares and savings programmes.

The chance to develop your skills within a global organization committed to your career growth.

A flexible hybrid working model aligned with modern work practices.

Key Words

biopharmaceutical

manufacturing

regulatory

risk assessment

Single-Use Systems

Extractables & Leachables

standardization

technology

compliance

continuous improvement

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Information Technology

Industries

Biotechnology Research and Pharmaceutical Manufacturing

#J-18808-Ljbffr