At a Glance
- 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 England employer: LinkedIn
As a CSV Engineer with our esteemed pharmaceutical client in the North East, you will be part of a dynamic team dedicated to ensuring the highest standards of software validation. The company fosters a collaborative work culture that prioritises employee growth through hands-on experience and professional development opportunities, all while working on impactful projects that contribute to healthcare advancements. Enjoy the unique advantage of being site-based, allowing for direct engagement with cutting-edge technology and processes in a supportive environment.
StudySmarter Expert Advice🤫
We think this is how you could land CSV Engineer in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work with CSV or 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. Be ready to discuss your hands-on experience with software validation and troubleshooting. We want you to shine when they ask about your field execution skills!
✨Tip Number 3
Showcase your problem-solving abilities! During interviews, share specific examples of how you've tackled challenges in past projects. This will demonstrate your expertise and make you stand out as a candidate.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace CSV Engineer in England
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 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!
Show Off Your Technical Skills:Don’t hold back on showcasing your technical expertise! Include details about your hands-on field execution experience, troubleshooting skills, and familiarity with regulations like GAMP5 and 21CFR Part 11. We need to know you can hit the ground running!
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. We can't wait to hear from you!
How to prepare for a job interview at LinkedIn
✨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, troubleshooting, and any relevant programming skills. The more specific examples you can provide, the better!
✨Understand the Regulations
Familiarise yourself with GMP regulations, GAMP5, and 21CFR Part 11. Being able to talk about how these regulations impact your work will show that you’re not just technically skilled but also aware of the compliance landscape.
✨Prepare for Scenario Questions
Expect questions that ask you to walk through your approach to risk assessments or handling deviations. Practise articulating your thought process clearly, as this will demonstrate your problem-solving abilities and technical expertise.
✨Show Your Team Spirit
Vendor management is a key part of this role, so be prepared to discuss how you’ve successfully collaborated with vendors in the past. Highlight any experiences where you’ve witnessed SAT documentation or managed vendor relationships effectively.
