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- Tasks: Support GMP informatics platforms and software for laboratory employees.
- Company: Dynamic and fast-growing company in the pharmaceutical sector.
- Benefits: Competitive salary, comprehensive benefits, and funding for training.
- Why this job: Make a real impact in a scientific environment and grow your career.
- Qualifications: Degree in Life Sciences or Computer Science; some IT or CSV experience preferred.
- Other info: Join a supportive team focused on excellence and innovation.
The predicted salary is between 30000 - 42000 £ per year.
We are looking for an enthusiastic and detail-oriented Computer System Validation (CSV) Associate to support the technical administration of GMP informatics platforms and software for Hoddesdon Analytical and Process Chemistry laboratory employees.
At Pharmaron we offer:
- Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy.
- Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
- A great team where we all support each other – enjoy your work!
Requirements:
- Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field.
- 0–2 years of experience working in IT or CSV support in the pharmaceutical or similar industry.
- General understanding of software development lifecycle (SDLC) and associated documentation with respect to regulatory compliance.
- Understanding of QMS, GMP, ALCOA+ and Data Integrity principles.
- Good understanding of laboratory systems, instruments, and associated software.
- Knowledge of IT systems Client Server environment, Windows, Data communications equipment (Routers, Switches, LAN / WAN, Data Backup and Restore) would be desirable.
- Some experience with coding (e.g. Python) would be desirable.
Key Roles and Responsibilities:
- Support R&D and QC laboratories as System Admin on 20+ systems.
- Support business critical roles as a back-up System Admin on Agilent OpenLab CDS and Revvity Signals (E3) ELN.
- Support validation activities for COTS systems.
- Draft validation documentation (IA, URS, FS, IQ, OQ, PQ, QP, TRM, QSR, etc.).
- Perform GMP Risk & Impact Assessments and Data Integrity Risk Assessments.
- Support creation, modification and removal of user accounts.
- Collaborate with IT and QA to manage system changes, upgrades, deviations and investigations within the QMS.
- Conduct periodic reviews for active systems.
- Support decommissioning activities for systems being retired from use.
- Provide technical support for validated systems.
- Participate in internal audits and support external inspections.
- Act as a liaison between business users and IT for system-related issues.
Our Company:
We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies. We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity.
Benefits:
- We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
- We offer state of the art working environment on site.
- We offer the opportunity for growth and development and will support funding for relevant training and development programmes.
Why Should You Apply?
This is an opportunity for you to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
CSV Associate in Hoddesdon employer: Pharmaron
Contact Detail:
Pharmaron Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSV Associate in Hoddesdon
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and practising common questions. Show them you’re not just another candidate; demonstrate your enthusiasm for their mission and how you can contribute to their success.
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. It shows your interest and professionalism, which is always a plus.
✨Tip Number 4
Don’t forget to apply through our website! We love seeing applications directly from candidates who are excited about joining our team. Plus, it helps us keep track of your application more easily.
We think you need these skills to ace CSV Associate in Hoddesdon
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the CSV Associate role. Highlight any relevant experience in IT or CSV support, and don’t forget to mention your understanding of software development lifecycle and regulatory compliance.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to express your enthusiasm for the role and the company. Share specific examples of how your skills align with the responsibilities listed in the job description.
Showcase Your Technical Skills: Don’t hold back on showcasing your technical skills! If you have experience with coding or knowledge of laboratory systems, make sure to include that. It’s all about demonstrating how you can contribute to our team.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you’re considered for the role without any hiccups!
How to prepare for a job interview at Pharmaron
✨Know Your Stuff
Make sure you brush up on your knowledge of Computer System Validation (CSV) principles, especially around GMP and data integrity. Familiarise yourself with the software development lifecycle (SDLC) and be ready to discuss how it relates to regulatory compliance.
✨Show Your Enthusiasm
Pharmaron is looking for someone enthusiastic about their work. Be sure to express your passion for the life sciences and technology during the interview. Share examples of how you've engaged with these fields in your studies or previous roles.
✨Prepare for Technical Questions
Expect some technical questions related to laboratory systems and IT environments. Brush up on your understanding of client-server architecture, Windows systems, and any coding experience you have, particularly with Python. Being able to speak confidently about these topics will set you apart.
✨Ask Insightful Questions
Prepare a few thoughtful questions to ask your interviewers. This could be about the team dynamics, opportunities for growth, or specific challenges they face in the CSV role. It shows you're genuinely interested in the position and the company.
