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- Tasks: Validate computer systems and support quality management activities in a dynamic team environment.
- Company: Join a leading firm focused on compliance and quality in regulated industries.
- Benefits: Enjoy flexible onsite work, professional growth opportunities, and a collaborative culture.
- Why this job: Make an impact by ensuring system integrity and compliance while working with diverse teams.
- Qualifications: B.S. in Computer Science or Engineering; 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.
Engineer field employer: Resolian UK
Contact Detail:
Resolian UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Engineer field
✨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.
✨Tip Number 2
Network with professionals in the field of Computer System Validation (CSV). Attend industry events or join relevant online forums to connect with others who may have insights into the role or even know about openings at StudySmarter.
✨Tip Number 3
Prepare to discuss your experience with cross-functional collaboration. Be ready to share examples of how you've worked with teams like IT, Quality Assurance, and Operations to solve complex problems, as this is a key aspect of the role.
✨Tip Number 4
Stay updated on the latest trends and best practices in CSV. Being knowledgeable about current industry developments will show that you're proactive and dedicated to continuous improvement, which is highly valued in this position.
We think you need these skills to ace Engineer field
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in validation and compliance with GxP regulations. Use specific examples that demonstrate your knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and how your background aligns with the responsibilities listed. Mention your experience with cross-functional teams and your problem-solving skills.
Highlight Relevant Skills: Clearly outline your skills related to CSV, SDLC, and Data Integrity principles. Provide examples of how you've successfully implemented best practices in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no grammatical errors and that all information is clear and concise, reflecting your excellent communication skills.
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.
