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- Tasks: Assist with software validation and manage vendor documentation for a pharmaceutical project.
- Company: Established pharmaceutical client with a focus on innovation and quality.
- Benefits: Competitive contract rate, hands-on experience, and potential for long-term engagement.
- Other info: Opportunity to work on exciting projects with excellent career growth potential.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Experience in software validation, Delta V, and strong troubleshooting skills.
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 PSSRGMP 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.
CSV Engineer in North East employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSV Engineer in North East
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the hunt for a CSV Engineer role. You never know who might have the inside scoop on an opportunity that’s not even advertised yet.
✨Tip Number 2
Prepare for those interviews by brushing up on your Delta V knowledge and software validation processes. We recommend doing mock interviews with friends or colleagues to get comfortable discussing your hands-on experience and troubleshooting skills.
✨Tip Number 3
Don’t forget to showcase your technical expertise! When you get the chance to chat with potential employers, highlight your experience with Risk Assessments, URS, and all that good stuff. Make sure they see how you can add value to their project.
✨Tip Number 4
Apply through our website! It’s super easy and ensures your application gets seen by the right people. Plus, we’re always looking for talented individuals like you to join our network in the pharmaceutical sector.
We think you need these skills to ace CSV Engineer in North East
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the CSV Engineer role. Highlight your experience with software validation, especially with Delta V, and any relevant automation background. 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 projects or experiences that relate to the responsibilities listed in the job description. Let us know why you’re excited about this opportunity!
Showcase Your Technical Skills: Don’t forget to highlight your technical skills in your application. We’re particularly interested in your hands-on experience with field execution, troubleshooting, and any programming knowledge. Make it easy for us to see your expertise!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it shows you’re keen on joining the StudySmarter team!
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. Be ready to discuss your hands-on experience with field execution and troubleshooting, as these are key areas for the role.
✨Prepare for Technical Questions
Expect questions about Risk Assessments, URS, DQ, and IOQ protocols. Familiarise yourself with the relevant regulations like GAMP5 and 21CFR Part 11, so you can confidently answer any technical queries thrown your way.
✨Showcase Your Problem-Solving Skills
Be prepared to share specific examples of how you've tackled challenges in past projects. Highlight your experience with vendor management and how you've resolved deviations, as this will demonstrate your capability in a real-world context.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the team dynamics, project timelines, or specific challenges they face. This shows your genuine interest in the role and helps you assess if it’s the right fit for you.