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- Tasks: Lead process validation and CPV in a cutting-edge biotech environment.
- Company: Innovative biotechnology company specialising in advanced cell and gene therapy.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Why this job: Join a fast-growing team and make a real impact in biotech manufacturing.
- Qualifications: 2-5 years in GMP manufacturing with strong problem-solving skills.
- Other info: On-site role in Stevenage with exposure to advanced therapies.
The predicted salary is between 36000 - 60000 £ per year.
Important: Visa sponsorship is not available for this role. Applicants must already have the right to work in the UK. Prior experience with Continued Process Verification (CPV) / Process Validation is essential. Title: Technical Associate II, MSAT (CPV / Process Validation SME) Location: Stevenage, UK (occasional London) Working Pattern: On-site 5 days per week. Fixed shifts also available if preffered About the Company A leading biotechnology company at the forefront of advanced cell and gene therapy. With a state-of-the-art site in Stevenage, they are delivering commercial manufacturing in the UK and already have products approved in the US. Their approach combines computational design with modular T-cell programming to develop adaptable therapies for cancer and autoimmune disease. The Opportunity This is an expansion role within MSAT, focused on process validation and CPV. You’ll act as the subject matter expert for validation activities, supporting GMP manufacturing and technology transfer. It’s a hands-on, fully on-site role offering exposure to ATMP manufacturing and commercial readiness in a fast-growing biotech. Key Responsibilities Act as SME for process validation and CPV, supporting routine GMP manufacturing. Provide floor and on-call support during tech transfer and batch execution. Conduct product impact assessments, root cause analysis, and CAPAs. Review and maintain GMP documentation including batch records, sampling plans, and material specifications. Contribute to CPV data entry, trending, and verification. Support technology transfer of new products into GMP. Represent MSAT in cross-functional teams and support process improvements. Requirements Essential: 2–5 years’ experience in GMP manufacturing. Direct experience with process validation or CPV. Strong technical writing, communication, and problem-solving skills. Ability to work independently and cross-functionally in a fast-paced environment. Fully on-site availability in Stevenage. Preferred: Experience in ATMP, biologics, or other regulated manufacturing. Background in technology transfer or process/product lifecycle management. Degree in science, engineering, or equivalent practical experience. Familiarity with QMS, deviations, CAPAs, and regulatory requirements. Exposure to aseptic processing, cell culture, or downstream processing. Experience with data analysis tools and continuous improvement methodologies.
MSAT Specialist – Process Validation & CPV employer: BioTalent
Contact Detail:
BioTalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land MSAT Specialist – Process Validation & CPV
✨Tip Number 1
Network like a pro! Reach out to people in the biotech industry, especially those working in MSAT or process validation. LinkedIn is your best mate here – connect, engage, and don’t be shy to ask for informational chats.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge. Since you’ll be acting as a subject matter expert, make sure you can confidently discuss CPV and process validation. Practice common interview questions and have examples ready to showcase your experience.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, be ready to discuss how you've tackled challenges in GMP manufacturing or tech transfer. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search. Good luck!
We think you need these skills to ace MSAT Specialist – Process Validation & CPV
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience with Continued Process Verification (CPV) and Process Validation. We want to see how your skills align with the role, so don’t be shy about showcasing relevant projects or achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your background makes you the perfect fit. We love seeing enthusiasm and a clear understanding of what we do at StudySmarter.
Showcase Your Technical Skills: Since this role requires strong technical writing and problem-solving skills, make sure to include examples that demonstrate these abilities. Whether it’s a project you led or a challenge you overcame, we want to see your expertise in action!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do and our company culture.
How to prepare for a job interview at BioTalent
✨Know Your Stuff
Make sure you brush up on your knowledge of Continued Process Verification (CPV) and process validation. Be ready to discuss your previous experiences in GMP manufacturing and how they relate to the role. This is your chance to show that you're the subject matter expert they need!
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled challenges in past roles, especially those involving root cause analysis and CAPAs. Companies love candidates who can think on their feet and come up with effective solutions, so have a few stories ready to share.
✨Get Familiar with Their Work Environment
Since this role is fully on-site, it’s important to understand the company culture and the specifics of their operations. Research their approach to ATMP manufacturing and be prepared to discuss how you can contribute to their goals in a fast-paced environment.
✨Ask Smart Questions
At the end of the interview, don’t forget to ask insightful questions about the team dynamics, ongoing projects, or future developments in CPV. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.