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- Tasks: Lead and manage CSV projects ensuring compliance with GXP regulations.
- Company: Join a dynamic team focused on quality and regulatory excellence in the tech industry.
- Benefits: Enjoy a permanent role with opportunities for professional growth and development.
- Why this job: Be part of a mission-driven company that values innovation and compliance in technology.
- Qualifications: Must have a B.Sc. in Computer Science or related field with 3+ years in CSV.
- Other info: Ideal for those passionate about improving processes in a regulated environment.
The predicted salary is between 42000 - 84000 £ per year.
Responsibilities
- Oversight and Compliance:
- IT CSV oversight for GXP computerized systems.
- Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5).
- Handling deviations, CAPAs, and change controls.
- Documentation and Review:
- Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability matrices, and validation summary reports.
- Collaboration:
- Ability to work independently on validation projects but also collaborate with cross-functional teams (IT, QA, Operations).
- Strong communication, problem solving and leadership in CSV processes.
- Issue Resolution and Communication:
- Identifying and resolving system issues.
- Communicating CSV requirements to senior management and stakeholders.
- Audit and Regulatory Support:
- Supporting external audit programs for vendors.
- Interfacing with regulatory agencies.
- Strategy and Improvement:
- Developing and implementing CSV strategies, policies, and procedures.
- Reviewing and approving validation documentation.
- Resource coordination, monitoring, and tracking of validation activities.
- Staying current with industry trends and regulatory changes.
- Continuous improvement of the CSV process.
- Flexibility and adaptability in a changing regulatory environment.
Education, Experience & Skills Required
- · Direct experience in leading, managing or participating in CSV projects in GxP environments.
- · B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years).
- · Extensive experience in regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements.
- · GLP /GCP /GMP experience is preferable.
- · Experience in supporting regulatory inspections.
CSV Engineer (permanent role) employer: Resolian UK
Contact Detail:
Resolian UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSV Engineer (permanent role)
✨Tip Number 1
Familiarize yourself with the specific regulations mentioned in the job description, such as 21 CFR Part 11 and EU Annex 11. Understanding these compliance requirements will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Highlight any previous experience you have with GxP environments and CSV projects. Be ready to discuss specific challenges you faced and how you overcame them, as this shows your problem-solving skills and leadership capabilities.
✨Tip Number 3
Prepare to showcase your ability to collaborate with cross-functional teams. Think of examples where you successfully worked with IT, QA, or Operations, as this is crucial for the role and will set you apart from other candidates.
✨Tip Number 4
Stay updated on industry trends and regulatory changes related to CSV processes. Being knowledgeable about recent developments can give you an edge during discussions with our team and show your proactive approach to continuous improvement.
We think you need these skills to ace CSV Engineer (permanent role)
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly understand the responsibilities and requirements of the CSV Engineer position. Highlight your relevant experience in GxP environments and compliance with regulations like 21 CFR Part 11 and EU Annex 11.
Tailor Your CV: Customize your CV to emphasize your direct experience in leading or participating in CSV projects. Include specific examples of your work with validation documentation and collaboration with cross-functional teams.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your problem-solving skills and leadership in CSV processes. Mention your ability to communicate effectively with senior management and stakeholders, as well as your experience in supporting regulatory inspections.
Highlight Continuous Improvement: In your application, discuss how you stay current with industry trends and regulatory changes. Provide examples of how you've contributed to the continuous improvement of CSV processes in your previous roles.
How to prepare for a job interview at Resolian UK
✨Understand the Regulations
Make sure you have a solid grasp of the key regulations mentioned in the job description, such as 21 CFR Part 11 and EU Annex 11. Be prepared to discuss how your experience aligns with these compliance requirements.
✨Showcase Your Documentation Skills
Be ready to provide examples of validation documentation you've created or reviewed. Highlight your experience with user requirements, validation plans, and risk assessments to demonstrate your attention to detail.
✨Emphasize Collaboration Experience
Since the role requires collaboration with cross-functional teams, share specific instances where you've successfully worked with IT, QA, or Operations. This will show your ability to communicate effectively and lead in CSV processes.
✨Prepare for Problem-Solving Questions
Expect questions about how you've identified and resolved system issues in the past. Think of concrete examples that showcase your problem-solving skills and adaptability in a regulated environment.
