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For Companies At a Glance
- Tasks: Be the go-to expert for Single-Use Systems and Extractables & Leachables in biopharmaceuticals.
- Company: Join a leading biopharmaceutical manufacturing site in Durham.
- Benefits: Enjoy competitive salary, bonuses, healthcare, and flexible hybrid working.
- Why this job: Make a real impact on sterile manufacturing processes for blockbuster products.
- Qualifications: Degree in Chemical Engineering or Pharmaceutical Sciences; E&L expertise required.
- Other info: Great career growth opportunities in a supportive global organisation.
The predicted salary is between 36000 - 60000 £ per year.
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.
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
MSAT Single-Use Systems and Extractables & Leachables Specialist in North East employer: Hyper Recruitment Solutions
Contact Detail:
Hyper Recruitment Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land MSAT Single-Use Systems and Extractables & Leachables Specialist in North East
✨Tip Number 1
Network like a pro! Reach out to professionals in the biopharmaceutical field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge related to Single-Use Systems and Extractables & Leachables. We recommend practising common interview questions and scenarios to showcase your expertise confidently.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your skills, making your application stand out.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe this small gesture can keep you top of mind for hiring managers.
We think you need these skills to ace MSAT Single-Use Systems and Extractables & Leachables Specialist in North East
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the MSAT Single-Use Systems and E&L role. Highlight your relevant experience in biopharmaceutical manufacturing, especially any work with Single-Use Systems and Extractables & Leachables. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you the perfect fit. Don’t forget to mention any specific projects or achievements that relate to the key duties outlined in the job description.
Show Off Your Technical Skills: Since this role requires strong technical writing and communication skills, make sure to showcase these in your application. Whether it's through your CV or cover letter, demonstrate your ability to convey complex information clearly and effectively. We love seeing candidates who can communicate across disciplines!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us that you’re genuinely interested in joining our team at StudySmarter!
How to prepare for a job interview at Hyper Recruitment Solutions
✨Know Your Stuff
Make sure you brush up on your knowledge of Single-Use Systems and Extractables & Leachables. Be ready to discuss specific materials, system designs, and sterility assurance protocols. This is your chance to show off your expertise!
✨Showcase Your Experience
Prepare examples from your past work that highlight your experience with multidisciplinary teams and risk management. Think about how you've contributed to compliance and performance improvements in previous roles—this will resonate well with the interviewers.
✨Communicate Clearly
Since strong communication skills are key for this role, practice explaining complex technical concepts in simple terms. You want to demonstrate that you can influence and negotiate effectively across various disciplines.
✨Ask Smart Questions
Come prepared with insightful questions about the company's approach to E&L and SUS. This shows your genuine interest in the role and helps you gauge if the company aligns with your career goals. Plus, it’s a great way to engage with your interviewers!
