CSV Engineer

CSV Engineer

Full-Time 40000 - 50000 £ / year (est.) No home office possible
X4 Life Sciences

At a Glance

  • Tasks: Validate software and ensure compliance in a dynamic pharmaceutical environment.
  • Company: Established pharmaceutical client with exciting projects and growth potential.
  • Benefits: Competitive contract rate, hands-on experience, and opportunity for long-term engagement.
  • Other info: Opportunity to work on cutting-edge technology in a supportive team.
  • Why this job: Join a vital project and make a real difference in the pharmaceutical industry.
  • Qualifications: Experience in software validation, Delta V, and strong troubleshooting skills.

The predicted salary is between 40000 - 50000 £ per year.

Location: North East (United Kingdom)

Employment Type: Contract

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.

CSV Engineer employer: X4 Life Sciences

Join a leading pharmaceutical company in the North East, where your expertise as a CSV Engineer will be valued and rewarded. With a strong commitment to employee development, you will benefit from a collaborative work culture that encourages innovation and offers opportunities for professional growth. Enjoy the unique advantage of working on impactful projects within a supportive environment that prioritises safety and compliance.
X4 Life Sciences

Contact Detail:

X4 Life Sciences 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 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.

✨Tip Number 2

Prepare for those interviews! Brush up on your Delta V knowledge and be ready to discuss your hands-on experience with software validation. We want you to shine when it comes to showcasing your skills.

✨Tip Number 3

Don’t forget to follow up! After an interview, shoot a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.

✨Tip Number 4

Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Let’s get you that CSV Engineer position!

We think you need these skills to ace CSV Engineer

Software Validation
Delta V
Risk Assessments
URS (User Requirements Specification)
DQ (Design Qualification)
RTM (Requirements Traceability Matrix)
IOQ Protocol and Reports
P&ID Walkdowns
Vendor FAT/SAT Documentation Review
PCS Interface Execution
Vendor Management
Deviation Management
Automation Troubleshooting
GMP Regulations
GAMP5
21CFR Part 11
EU Annex 11
Data Integrity Requirements

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. Let us know what makes you tick!

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 and troubleshooting. Make sure these skills stand out so we can see your expertise at a glance!

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 any important updates. Plus, it’s super easy – just a few clicks and you’re done!

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 processes. Be ready to discuss your hands-on experience with risk assessments, URS, and protocol generation. The more specific examples you can provide, the better!

✨Showcase Your Troubleshooting Skills

Prepare to talk about your troubleshooting experiences during field execution. Think of a couple of challenging situations you've faced and how you resolved them. This will demonstrate your problem-solving abilities and hands-on expertise.

✨Familiarise Yourself with Regulations

Since the role involves compliance with GMP regulations and GAMP5, make sure you’re well-versed in these areas. Being able to discuss how you’ve applied these regulations in past projects will show that you’re the right fit for the job.

✨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. This shows your genuine interest in the role and helps you assess if it’s the right fit for you.

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