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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 opportunities for professional growth.
- Why this job: Be part of a collaborative culture that values innovation and continuous improvement in validation processes.
- Qualifications: B.S. in Computer Science or related field with 2-4 years of validation experience required.
- Other info: No relocation offered; must be able to adapt to changing priorities.
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. Being able to discuss these regulations confidently during your interview will demonstrate your expertise and commitment to compliance.
✨Tip Number 2
Network with professionals in the CSV field, especially those who have experience in regulated industries. Attend relevant industry events or webinars to make connections and gain insights that could help you stand out as a candidate.
✨Tip Number 3
Prepare to discuss specific examples of how you've improved CSV processes in previous roles. Highlighting your problem-solving skills and ability to implement best practices will show that you're proactive and results-oriented.
✨Tip Number 4
Research StudySmarter and our values, particularly how we approach quality management and compliance. Tailoring your conversation to align with our mission can help you make a strong impression during the interview process.
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 role. Mention specific experiences that demonstrate your ability to validate computerized systems and collaborate with cross-functional teams.
Showcase Your Skills: Clearly outline your skills related to problem-solving, analytical thinking, and communication. Provide examples of how you've successfully navigated challenges in previous roles, particularly in relation to compliance and validation.
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.
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 previous work. Highlight your attention to detail and ability to produce clear, compliant documents like risk assessments and validation plans.
✨Demonstrate Cross-Functional Collaboration
Prepare to discuss your experience working with various teams, such as IT and Quality Assurance. Share specific examples of how you’ve successfully collaborated to resolve system issues or improve processes.
✨Stay Current with Industry Trends
Show that you are proactive about keeping up with industry changes and best practices related to CSV. Mention any recent training, certifications, or resources you follow to stay informed, demonstrating your commitment to continuous improvement.
