Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Validate computer systems and ensure compliance with industry regulations.
- Company: Leading company in regulated industries focused on quality and innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Join a dynamic team and make a real impact on system validation processes.
- Qualifications: Degree in Computer Science or Engineering; 2-4 years of validation experience required.
- Other info: Collaborative environment with a focus on continuous improvement and career advancement.
The predicted salary is between 36000 - 60000 £ per year.
Validate computerized systems in accordance with 21 CFR Part 11, EU Annex 11, OECD 17, and GAMP 5. Support CSV activities of the Quality Management System including deviations, CAPAs, and change controls related to GxP computerized systems. Review and create validation documentation - such as risk assessments, user requirements functional specifications, validation plans, IQ/OQ/PQ documentation, traceability matrices, and validation summary reports. Collaborate with cross-functional teams, including vendors, IT, Quality Assurance, and Operations, to ensure the successful validation of computer systems and software applications. Effectively identify and resolve system issues and appropriately communicate gating items to senior management and stakeholders. Support the external audit program for vendors related to GxP computerized systems. May support and interface with regulatory agencies and audits as required in support of regulatory agency inspections, including presenting validation strategies and justification of risk-based decisions taken. Review and approve validation documentation, ensuring accuracy, completeness, and compliance with regulatory requirements and company policies. Continuously improving the CSV process by identifying areas for enhancement and implementing best practices.
Skills, Education & Qualifications
- B.S. degree in Computer Science, Engineering, or relevant scientific field.
- Minimum 2-4 years’ direct validation experience within regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, EU Annex 11, and GAMP 5 requirements.
- Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity principles.
- Must be able to stay current with industry trends, regulatory changes, and best practices related to CSV to improve in-house CSV process by identifying areas for enhancement and implementing best practices.
- Must possess understanding of GCP, GLP, and GMP principles and procedures.
- Must possess excellent verbal and written communication skills.
- Proficient in MS Word and other Office applications.
- A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives.
- Should be an analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
CSV Engineer in Fordham employer: Resolian
Contact Detail:
Resolian Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSV Engineer in Fordham
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend relevant meetups or webinars, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GxP regulations and validation processes. Practice common interview questions related to CSV and be ready to discuss your past experiences in detail. Confidence is key!
✨Tip Number 3
Showcase your problem-solving skills during interviews. Be prepared to share examples of how you've identified and resolved system issues in the past. This will demonstrate your analytical thinking and ability to adapt to challenges.
✨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 Fordham
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experience mentioned in the job description. Highlight your validation experience and knowledge of GxP regulations to show us you're the right fit for the CSV Engineer role.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about CSV and how your background aligns with our needs. Share specific examples of your past work that demonstrate your problem-solving skills and ability to collaborate with cross-functional teams.
Showcase Your Technical Skills: Don’t forget to mention your proficiency in MS Word and other Office applications. We want to see how you’ve used these tools in your previous roles, especially in creating validation documentation and reports.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the CSV Engineer position. Plus, it shows us you’re keen on joining our team!
How to prepare for a job interview at Resolian
✨Know Your Regulations
Make sure you brush up on 21 CFR Part 11, EU Annex 11, and GAMP 5 before the interview. Being able to discuss these regulations confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Documentation Skills
Prepare examples of validation documentation you've worked on, like risk assessments or validation plans. Being able to talk through your experience with these documents will demonstrate your hands-on knowledge and attention to detail.
✨Collaboration is Key
Be ready to discuss how you've collaborated with cross-functional teams in the past. Highlight specific instances where you worked with IT, Quality Assurance, or Operations to solve problems or improve processes, as teamwork is crucial in this role.
✨Stay Current and Adaptable
Show your awareness of industry trends and regulatory changes. Discuss how you've adapted your CSV processes in response to new information or best practices, which will illustrate your proactive approach and commitment to continuous improvement.
