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- Tasks: Assist in software validation and risk assessments for pharmaceutical projects.
- Company: Established pharmaceutical client with a focus on innovation.
- Benefits: Competitive contract rate, hands-on experience, and potential for long-term work.
- Other info: Opportunity for professional growth in a supportive environment.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Experience in validation, automation, and strong troubleshooting skills required.
The predicted salary is between 40000 - 50000 £ per year.
A well-established pharmaceutical client is looking for a CSV Engineer to assist with their ongoing project. This will be a 6 month initial project, with the total workload expected to run for 9-12 months. The role is heavily focused on software validation (Delta V), and needs a fully site based professional.
Responsibilities will include:
- Generation of execution of Risk Assessments, URS, DQ, RTM and IOQ protocol and IOQ Reports
- P&ID Walkdowns
- Review of Vendor FAT / SAT documentation and vendor TTOPs
- Execution of systems with PCS interface
- Vendor Management during SAT execution, witnessing and signing SAT documentation on behalf of client
- Raising of deviations through to their resolution and closure of deviation
Technical Requirements:
- Strong hands-on field execution experience from start-up / energization to shakedown and testing
- Delta V
- Strong automation background for troubleshooting
- Ideally experience with programming / coding
- Strong trouble shooting experience during field execution
- Familiar with LOTO, Safe Plan of Action and PSSR
- GMP regulations, GAMP5, 21CFR Part 11, EU Annex 11, Data Integrity requirements
If you have a strong background in Validation and Automation, then please get in touch to discuss further.
Risk Engineer (Projects) employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Risk Engineer (Projects)
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience with CSV and Delta V. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge. Make sure you can confidently discuss your hands-on experience with software validation and automation. We want you to shine when they ask about your troubleshooting skills!
✨Tip Number 3
Don’t forget to showcase your project experience! Be ready to talk about specific projects where you executed risk assessments or managed vendor documentation. This will help you stand out as someone who knows their stuff.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and take the initiative to connect directly with us.
We think you need these skills to ace Risk Engineer (Projects)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Risk Engineer role. Highlight your experience with software validation, especially with Delta V, and any relevant projects you've worked on. We want to see how your skills match 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 the perfect fit for this role. Mention specific experiences that relate to the responsibilities listed in the job description. We love a good story!
Showcase Your Technical Skills: Don’t forget to highlight your technical skills in your application. Mention your hands-on field execution experience, troubleshooting abilities, and familiarity with GMP regulations. We’re looking for someone who can hit the ground running!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. We can’t wait to hear from you!
How to prepare for a job interview at X4 Life Sciences
✨Know Your Stuff
Make sure you brush up on your knowledge of Delta V and software validation. Familiarise yourself with the technical requirements listed in the job description, like GMP regulations and GAMP5. Being able to discuss these topics confidently will show that you're serious about the role.
✨Prepare for Practical Questions
Expect questions that dive into your hands-on experience with field execution and troubleshooting. Think of specific examples from your past work where you successfully managed risk assessments or vendor management during SAT execution. This will help you demonstrate your practical skills effectively.
✨Show Your Problem-Solving Skills
Since the role involves raising deviations and resolving them, be ready to discuss how you've tackled similar challenges before. Prepare a couple of scenarios where you identified a problem, implemented a solution, and what the outcome was. This will highlight your critical thinking and troubleshooting abilities.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the team dynamics, ongoing projects, or how success is measured in this role. This shows your interest in the position and helps you gauge if it’s the right fit for you.