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- Tasks: Validate computer systems in a dynamic pharmaceutical environment and ensure compliance with industry regulations.
- Company: Join a leading pharmaceutical manufacturer on an exciting capital project.
- Benefits: Competitive contract rate, professional development opportunities, and a chance to work on innovative projects.
- Other info: Exciting opportunity for growth in a fast-paced, regulated industry.
- Why this job: Make a real impact by ensuring the reliability of critical systems in healthcare.
- Qualifications: Degree in Science, Engineering, IT or equivalent experience; knowledge of cGMP and GAMP 5 required.
The predicted salary is between 36000 - 60000 £ per year.
Computer System Validation (CSV) Engineer
📍 Location: Surrey | 💼 Contract | 🏭 Pharmaceutical Manufacturing
We are on the hunt for Computer System Validation (CSV) Engineer to join our client for an exciting capital project involving a new production line. This role is critical in ensuring that all computerised systems are validated, compliant, and operate reliably in accordance with GxP and industry regulations.
You will be working with a variety of systems, including Sartorius and SAP alongside other GxP-regulated systems within a manufacturing environment.
Key Responsibilities
- Validation Protocols: Develop and execute IQ, OQ, and PQ protocols across a range of systems.
- Documentation: Prepare and maintain validation documentation, including plans, test scripts, traceability matrices, and summary reports.
- Risk Management: Perform risk assessments and impact analyses to identify critical functionalities and vulnerabilities.
- Change Control: Assess system changes and ensure appropriate validation activities are undertaken.
- Regulatory Support: Support audits and inspections by providing documentation and expert input on CSV processes.
What You Need:
- Degree in Science, Engineering, IT or related discipline, or equivalent practical experience.
- Strong knowledge of cGMP, GAMP 5 and relevant regulatory requirements.
- Experience with validation in pharma, biotech, or medical devices.
- Familiarity with systems such as Sartorius and SAP
CSV Engineer employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSV Engineer
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work with CSV. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Get your hands dirty with some practical experience. If you can, volunteer or take on freelance projects related to computer system validation. This not only boosts your CV but also gives you real-world examples to discuss in interviews.
✨Tip Number 3
Prepare for interviews by brushing up on GxP and cGMP regulations. We all know how crucial these are in the pharma world, so being able to speak confidently about them will set you apart from the competition.
✨Tip Number 4
Don't forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to keep track of your applications!
We think you need these skills to ace CSV Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the CSV Engineer role. Highlight your experience with validation protocols and any relevant systems like Sartorius and SAP. We want to see how your background fits perfectly with what we're looking for!
Showcase Your Skills: In your cover letter, don’t just list your qualifications; showcase your skills! Talk about your experience with GxP regulations and risk management. We love seeing how you can bring value to our team.
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read. We appreciate straightforward communication that gets to the point!
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. We can’t wait to see what you’ve got!
How to prepare for a job interview at Blackfield Associates
✨Know Your CSV Basics
Make sure you brush up on your knowledge of Computer System Validation principles, especially GxP and GAMP 5. Being able to discuss these concepts confidently will show that you understand the core requirements of the role.
✨Familiarise Yourself with Key Systems
Since the job involves working with systems like Sartorius and SAP, take some time to learn about their functionalities and how they fit into the validation process. This will help you answer technical questions more effectively.
✨Prepare for Scenario Questions
Expect to be asked about specific scenarios related to validation protocols, risk management, and change control. Think of examples from your past experience where you successfully navigated these challenges and be ready to share them.
✨Documentation is Key
Be prepared to discuss your experience with validation documentation. Highlight your familiarity with creating plans, test scripts, and summary reports, as this is crucial for the role. Bring examples if possible!