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For Companies At a Glance
- Tasks: Validate computer systems and ensure compliance with industry regulations.
- Company: Join a dynamic team at a leading company in the regulated industry.
- Benefits: Enjoy flexible onsite work a few days a week and collaborative team culture.
- Why this job: Make an impact by improving processes and working with cross-functional teams.
- Qualifications: B.S. in Computer Science or related field; 2-4 years of validation experience required.
- Other info: Opportunity to engage with regulatory agencies 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 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 inhouse 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.
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 that could lead to valuable insights or referrals for the position.
✨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 set you apart from other candidates.
✨Tip Number 4
Research StudySmarter and our approach to CSV. Understanding our company culture and values will help you tailor your responses during the interview, showing that you're not just a fit for the role but also for our team.
We think you need these skills to ace CSV Engineer (onsite a few days a week)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for 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 connects your background to the job description. Mention specific experiences where you've successfully validated systems or improved processes, and express your enthusiasm for the role and the company.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. Ensure that your documents are clear, concise, and free from typos, as attention to detail is critical in this field.
How to prepare for a job interview at Resolian UK
✨Know Your Regulations
Familiarise yourself with key regulations such as 21 CFR Part 11, EU Annex 11, and GAMP 5. Be prepared to discuss how your experience aligns with these standards and how you can ensure compliance in the role.
✨Showcase Your Documentation Skills
Be ready to talk about your experience in creating and reviewing validation documentation. Highlight specific examples of risk assessments, validation plans, or traceability matrices you've worked on, demonstrating your attention to detail and understanding of regulatory requirements.
✨Emphasise Team Collaboration
This role requires working with cross-functional teams. Share examples of how you've successfully collaborated with IT, Quality Assurance, or Operations in past roles, focusing on your communication skills and ability to resolve issues effectively.
✨Stay Current with Industry Trends
Demonstrate your commitment to continuous improvement by discussing how you keep up with industry trends and regulatory changes. Mention any recent developments in CSV that you find interesting and how they could impact the role you're applying for.
