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- Tasks: Lead process validation and CPV in a cutting-edge biotech environment.
- Company: Join a leading biotechnology firm revolutionising cell and gene therapy.
- Benefits: Competitive salary, hands-on experience, and growth in a fast-paced industry.
- Why this job: Be at the forefront of innovative therapies and make a real impact.
- Qualifications: 2-5 years in GMP manufacturing with strong problem-solving skills.
- Other info: On-site role in Stevenage with opportunities for career advancement.
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 prefferedAbout the CompanyA 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 OpportunityThis 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 ResponsibilitiesAct 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.RequirementsEssential: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: LinkedIn
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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. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge related to CPV and process validation. We recommend practising common interview questions and scenarios that might come up, so you can showcase your expertise confidently.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds and shows your enthusiasm.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at the forefront of biotechnology.
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 the MSAT Specialist role. Highlight your experience with Continued Process Verification (CPV) and Process Validation, as these are key for us. Use specific examples that showcase your skills and achievements in GMP manufacturing.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about biotechnology and how your background makes you a perfect fit for our team. Don’t forget to mention your hands-on experience and problem-solving skills!
Showcase Your Technical Skills: We love seeing strong technical writing and communication skills. Make sure to include any relevant projects or experiences that demonstrate your ability to work independently and cross-functionally. This will help us see how you can contribute to our fast-paced environment.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team at the forefront of advanced cell and gene therapy!
How to prepare for a job interview at LinkedIn
✨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. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewer to see your thought process.
✨Get Familiar with the Company
Research the biotechnology company and their approach to advanced cell and gene therapy. Understanding their products and the technology they use will help you align your answers with their goals and demonstrate your genuine interest in the role.
✨Ask Smart Questions
Prepare thoughtful questions about the MSAT team, the technology transfer process, and how success is measured in this role. This not only shows your enthusiasm but also helps you gauge if the company culture and expectations align with what you're looking for.