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- Tasks: Validate software for medical devices and ensure compliance with industry standards.
- Company: Established pharmaceutical company focused on innovation and quality.
- Benefits: Competitive pay, contract role with potential for extension, and hands-on experience.
- Other info: Opportunity to work in a dynamic environment with career growth potential.
- Why this job: Join a vital project that impacts healthcare and enhances your technical skills.
- 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 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.
Engineer medical device employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Engineer medical device
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device and pharmaceutical sectors on LinkedIn. Join relevant groups, attend webinars, and don’t be shy about asking for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews! Research common questions for CSV Engineers and practice your answers. We recommend using the STAR method (Situation, Task, Action, Result) to structure your responses. This will help you showcase your hands-on experience and problem-solving skills effectively.
✨Tip Number 3
Showcase your skills! Create a portfolio or a project summary that highlights your experience with Delta V, automation troubleshooting, and any relevant programming work. We want to see your practical knowledge in action, so make it visually appealing and easy to digest.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can give you an edge. Plus, it’s super easy to keep track of your applications and get updates. Let’s land that CSV Engineer role together!
We think you need these skills to ace Engineer medical device
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 skills. We want to see how your background fits perfectly with 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. We love a good story!
Showcase Your Technical Skills: Don’t forget to highlight your technical skills in your application. Mention your hands-on experience with field execution, troubleshooting, and any programming knowledge you have. We’re keen on seeing how you can contribute to our team!
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. Plus, it’s super easy!
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
Be ready to discuss how you've tackled challenges in previous projects. Highlight your experience with raising deviations and how you resolved them. This will showcase your ability to think critically and act decisively under pressure, which is crucial for this role.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the team dynamics, project timelines, or specific challenges they face with the current project. This shows your genuine interest in the position and helps you gauge if it’s the right fit for you.