Back to Job SearchROLE OVERVIEW
We 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.
Based within a state-of-the-art site, the successful candidate will play a critical role in establishing industry-leading standards, supporting continuous improvement initiatives, and ensuring the highest levels of quality and safety in our client's manufacturing operations.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the MSAT Single-Use Systems and E&L Specialist will be varied, however, the key duties and responsibilities are as follows:
- 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
To be successful in your application to this exciting role as the MSAT Single-Use Systems and E&L Specialist we are looking to identify the following on your profile and past history:
- 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?
Joining our client provides an exceptional opportunity to work within a cutting-edge, innovative environment dedicated to continuous improvement and industry excellence. You’ll benefit from:
- 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".
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.
