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- Tasks: Validate computer systems and support quality management activities in a regulated environment.
- Company: Join a dynamic team focused on ensuring compliance and quality in technology-driven industries.
- Benefits: Enjoy flexible onsite work a few days a week and gain valuable industry experience.
- Why this job: Be part of a crucial role that impacts quality assurance and regulatory compliance in tech.
- Qualifications: B.S. in Computer Science or related field with 2-4 years of validation experience required.
- Other info: Opportunity to collaborate with cross-functional teams and enhance your professional skills.
The predicted salary is between 36000 - 60000 £ per year.
Onsite a few days a week in Fordham. No relocation offered for this role.
Responsibilities
- 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 improve 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 (onsite a few days a week) employer: Resolian UK
Contact Detail:
Resolian UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSV Engineer (onsite a few days a week)
✨Tip Number 1
Familiarise yourself with the specific regulations mentioned in the job description, such as 21 CFR Part 11 and GAMP 5. Understanding these guidelines will not only help you during interviews but also demonstrate your commitment to compliance and quality in CSV.
✨Tip Number 2
Network with professionals in the CSV field, especially those who have experience in regulated industries. Engaging with industry groups or attending relevant conferences can provide insights and connections that may lead to job opportunities.
✨Tip Number 3
Prepare to discuss your previous experiences with validation documentation and cross-functional collaboration. Be ready to share specific examples of how you've successfully navigated challenges in these areas, as this will showcase your practical knowledge and problem-solving skills.
✨Tip Number 4
Stay updated on the latest trends and best practices in CSV by following relevant publications and online forums. This knowledge will not only enhance your expertise but also show potential employers that you are proactive and dedicated to continuous improvement in your field.
We think you need these skills to ace CSV Engineer (onsite a few days a week)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in CSV and validation within regulated industries. Emphasise your knowledge of GxP, 21 CFR Part 11, and other key regulations mentioned in the job description.
Craft a Strong Cover Letter: In your cover letter, explain why you are a great fit for the CSV Engineer role. Mention specific experiences that demonstrate your skills in validation documentation and collaboration with cross-functional teams.
Showcase Your Communication Skills: Since excellent verbal and written communication skills are essential for this role, consider including examples of how you've effectively communicated complex information to stakeholders or senior management in your application.
Highlight Continuous Improvement Initiatives: Discuss any past experiences where you identified areas for enhancement in processes or systems. This will show your proactive approach to improving CSV processes, which is a key responsibility of the role.
How to prepare for a job interview at Resolian UK
✨Know Your Regulations
Familiarise yourself with 21 CFR Part 11, EU Annex 11, and GAMP 5. Be prepared to discuss how these regulations impact your work and provide examples of how you've applied them in past roles.
✨Showcase Your Documentation Skills
Since the role involves creating and reviewing validation documentation, bring samples of your previous work or be ready to discuss your experience with risk assessments, validation plans, and traceability matrices.
✨Emphasise Team Collaboration
Highlight your experience working with cross-functional teams. Be ready to share specific examples of how you’ve collaborated with IT, Quality Assurance, and Operations to resolve system issues or improve processes.
✨Demonstrate Problem-Solving Abilities
Prepare to discuss a challenging situation you faced in a previous role and how you approached it. Focus on your analytical thinking and adaptability to changing priorities, as these are key skills for this position.
