At a Glance
- Tasks: Lead CSV projects in pharma and biotech, ensuring compliance and quality.
- Company: Join a global leader in validation and compliance services.
- Benefits: Competitive salary, professional growth, and a collaborative culture.
- Other info: Opportunity for career advancement and involvement in meaningful projects.
- Why this job: Make a real impact with cutting-edge technologies in a dynamic environment.
- Qualifications: Experience in CSV, GxP, and strong technical writing skills required.
The predicted salary is between 45000 - 55000 £ per year.
Exciting opportunity for experience CSV Engineers with Ellab UK.
As part of a trusted global leader in validation, monitoring, and compliance services, you’ll work with cutting‑edge technologies and blue‑chip pharma, biotech, and medical device clients.
We offer meaningful projects, professional growth, and a collaborative, high‑standards culture where your expertise in CSV makes a real impact.
Responsibilities
- Lead risk‑based CSV across the full system lifecycle (implementation to retirement) in Gx P environments.
- Develop and execute validation deliverables: VMP/VP, URS, risk assessments, test scripts, IQ/OQ/PQ, traceability, VSR.
- Ensure compliance with GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity.
- Plan and run testing, document results accurately, investigate deviations, and close actions promptly.
- Manage Change Control, Deviations, CAPA, and Periodic Reviews to maintain validated state.
- Collaborate with QA, IT, Engineering, Automation, and Operations on scoping, delivery, and sustainment.
- Validate platforms such as LIMS, MES, EMS/BMS, SCADA/PLC, QMS, ERP, temperature monitoring, and lab systems.
- Apply CQV and risk‑based approaches to size effort and ensure fit‑for‑purpose compliance.
- Prepare for and support regulatory inspections and customer audits.
- Produce high‑quality GMP/GDP documentation with end‑to‑end requirements‑to‑test traceability.
- Run multiple validation workstreams independently; communicate status, risks, and decisions clearly.
- Drive continuous improvement of CSV processes, templates, and standards.
Requirements
- Proven CSV experience in regulated pharma/biotech/medical device/healthcare.
- Strong knowledge of GAMP 5, Gx P, FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+.
- Hands‑on with validation docs: VP/VMP, URS, risk assessments, test scripts, IQ/OQ/PQ, traceability, VSR.
- End‑to‑end lifecycle validation experience (implementation through retirement).
- Skilled in developing/executing test scripts and documenting results accurately.
- Experience with Change Control, Deviations, CAPA, and Periodic Reviews.
- Applied risk‑based validation and system lifecycle management.
- GMP/GDP documentation standards and Good Documentation Practice.
- Cross‑functional collaboration with QA, IT, Engineering, Automation, and Operations.
- Excellent technical writing, communication, analytical, and problem‑solving skills.
- Able to manage multiple projects independently with strong organization.
- Degree in Engineering, Computer Science, Life Sciences, Pharmaceutical Sciences, or equivalent experience.
- Validation of LIMS, MES, EMS/BMS, SCADA/PLC, QMS, ERP, temperature monitoring, calibration/lab systems.
- Support for regulatory inspections and customer audits.
- Knowledge of CQV; client‑facing project experience.
- Flexible to travel; full UK driving licence
If this sounds like you please feel free to click apply.
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CSV Engineer in Newcastle upon Tyne employer: Ellab
At Ellab UK, we pride ourselves on being a leading employer in the validation and compliance sector, offering CSV Engineers the chance to work with innovative technologies and prestigious clients in the pharma and biotech industries. Our collaborative culture fosters professional growth and meaningful contributions, ensuring that your expertise not only enhances your career but also makes a significant impact on the industry. With a commitment to high standards and continuous improvement, we provide an environment where you can thrive and develop your skills while working on exciting projects.
StudySmarter Expert Advice🤫
We think this is how you could land CSV Engineer in Newcastle upon Tyne
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Ellab. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Ellab.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Ellab. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Ellab is looking for. A tailored application can really make you stand out!
We think you need these skills to ace CSV Engineer in Newcastle upon Tyne
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Ellab!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Ellab that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Ellab!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Ellab, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Ellab
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Ellab that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Ellab’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
