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- Tasks: Validate computer systems and support quality management activities in a dynamic biotech environment.
- Company: Join Resolian UK, a leader in biotechnology research and services.
- Benefits: Enjoy flexible onsite work, competitive salary, and opportunities for professional growth.
- Why this job: Be part of a collaborative team making a real impact in regulated industries.
- Qualifications: B.S. in Computer Science or related field; 2-4 years validation experience required.
- Other info: Opportunity to interface with regulatory agencies and enhance CSV processes.
The predicted salary is between 36000 - 60000 £ per year.
4 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Resolian UK 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, 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 successful validation of computer systems and software applications. Identify and resolve system issues effectively, communicating gating items to senior management and stakeholders. Support the external audit program for vendors related to GxP computerized systems. Interface with regulatory agencies and audits as required, presenting validation strategies and justifying risk-based decisions. 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’ validation experience within regulated industries, with knowledge of GxP, 21 CFR Part 11, OECD 17, EU Annex 11, and GAMP 5. Experience with CSV, SDLC, and Data Integrity principles. Ability to stay current with industry trends, regulatory changes, and best practices to enhance CSV processes. Understanding of GCP, GLP, and GMP principles and procedures. Excellent verbal and written communication skills. Proficiency in MS Word and Office applications. Strong team player with the ability to work independently and cross-functionally, with analytical thinking and problem-solving skills, adaptable to changing priorities. Seniority level Associate Employment type Full-time Job function Information Technology Industries Biotechnology Research and Research Services #J-18808-Ljbffr
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 show that you have a solid understanding of the compliance landscape.
✨Tip Number 2
Network with professionals in the CSV field, especially those who work in regulated industries like biotechnology. Engaging with them on platforms like LinkedIn can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with cross-functional collaboration. Think of specific examples where you've worked with IT, Quality Assurance, or Operations teams to resolve system issues or improve processes, as this is a key aspect of the role.
✨Tip Number 4
Stay updated on the latest trends and best practices in CSV and data integrity. Mentioning recent developments or tools during your conversation can demonstrate your commitment to continuous improvement and your proactive approach to the role.
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 validation within regulated industries. Emphasise your knowledge of GxP, 21 CFR Part 11, and other regulations mentioned in the job description.
Craft a Strong Cover Letter: In your cover letter, explain why you are passionate about CSV and how your background aligns with the responsibilities listed. Mention specific projects or experiences that demonstrate your skills in validation documentation and cross-functional collaboration.
Showcase 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 during audits in your application.
Highlight Continuous Improvement Initiatives: Discuss any initiatives you've led or contributed to that improved CSV processes. This shows your proactive approach and commitment to enhancing practices, which is a key aspect of the 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. Being able to discuss these regulations confidently will show your understanding of the industry standards.
✨Showcase Your Documentation Skills
Prepare examples of validation documentation you've worked on, like risk assessments or validation plans. Highlighting your experience in creating and reviewing these documents will demonstrate your capability in this role.
✨Emphasise Team Collaboration
Be ready to discuss how you've collaborated with cross-functional teams in the past. Share specific examples of how you communicated effectively with IT, Quality Assurance, and Operations to resolve issues.
✨Stay Current with Industry Trends
Research recent trends and changes in the CSV field. Showing that you are proactive about staying informed will impress interviewers and indicate your commitment to continuous improvement in the CSV process.
