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- Tasks: Validate computer systems and ensure compliance with regulatory standards.
- Company: Join a leading firm focused on quality management in regulated industries.
- Benefits: Enjoy flexible onsite work a few days a week and gain valuable experience.
- Why this job: Be part of a dynamic team improving processes that impact public health and safety.
- Qualifications: B.S. in Computer Science or related field; 2-4 years validation experience required.
- Other info: Opportunity to collaborate with cross-functional teams and engage with regulatory agencies.
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) (Fordham) 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) (Fordham)
✨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 about your professional development.
We think you need these skills to ace CSV Engineer (onsite a few days a week) (Fordham)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the CSV Engineer position. Familiarise yourself with terms like GxP, 21 CFR Part 11, and GAMP 5, as these will be crucial in your application.
Tailor Your CV: Customise your CV to highlight relevant experience in validation within regulated industries. Emphasise your knowledge of compliance standards and any specific projects that demonstrate your skills in CSV and SDLC.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for the role and your understanding of the CSV process. Mention specific experiences where you've successfully collaborated with cross-functional teams or improved processes.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no spelling or grammatical errors, and that all information is clear and concise. A polished application reflects your attention to detail, which is vital for this role.
How to prepare for a job interview at Resolian UK
✨Know Your Regulations
Familiarise yourself with the key regulations mentioned in the job description, such as 21 CFR Part 11 and GAMP 5. Be prepared to discuss how your experience aligns with these standards and how you can ensure compliance in your role.
✨Showcase Your Documentation Skills
Since the role involves reviewing and creating validation documentation, bring examples of your past work or be ready to discuss your approach to creating risk assessments and validation plans. Highlight your attention to detail and understanding of regulatory requirements.
✨Emphasise Team Collaboration
This position requires collaboration with various teams. Prepare examples of how you've successfully worked with cross-functional teams in the past, particularly in resolving system issues or during audits. This will demonstrate your ability to communicate effectively and work well with others.
✨Stay Current with Industry Trends
Demonstrate your commitment to continuous improvement by discussing how you keep up with industry trends and regulatory changes. Share any recent learnings or best practices you've implemented in your previous roles to enhance CSV processes.
