CSV Engineer (Computer System Validation Engineer)

What are we looking for in our CSV Engineer (Computer System Validation Engineer)?

Russell Tobin partners with a leading global biologics manufacturer renowned for its commitment to improving the health and well-being of both patients and staff. Recognized as one of Ireland's premier large workplaces, they consistently demonstrate a dedication to driving meaningful change in their daily operations. 

Exciting Opportunity Alert! 🚀

Join Our Team as a CSV Engineer (Computer System Validation Engineer)!

Are you passionate about ensuring compliance and maintaining cutting-edge computerized systems in a regulated environment? We're seeking a skilled CSV Engineer to validate and maintain our computer systems, ensuring they meet regulatory requirements and industry standards.

Responsibilities:

1. Develop and execute validation protocols for computer systems and software applications.
2. Collaborate with cross-functional teams to ensure compliance with regulatory guidelines.
3. Perform risk assessments and impact analyses to identify critical system functionalities.
4. Create and maintain validation documentation, including plans and test scripts.
5. Conduct periodic reviews to ensure ongoing compliance.
6. Participate in change control processes, assessing the impact of system changes.
7. Provide guidance and support to project teams regarding CSV principles.
8. Stay updated with industry trends and regulatory changes.
9. Collaborate with vendors to ensure compliance with validation requirements.
10. Support regulatory inspections and audits.

Additional Responsibilities:

• Qualification of laboratory analytical instruments.
• Qualification of manufacturing automation systems.

Requirements:

1. Bachelor's degree in Computer Science, Engineering, or related field.
2. Strong knowledge of regulatory guidelines (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
3. Experience in CSV within regulated industries.
4. Familiarity with validation methodologies, including risk-based approaches.
5. Proficiency in creating and executing validation protocols.
6. Excellent analytical and problem-solving skills.
7. Strong communication and interpersonal skills.
8. Ability to work independently and manage multiple projects.
9. Knowledge of SDLC and change control processes.
10. Understanding of data integrity principles.

Ready to take the next step in your career? Apply now and be part of a dynamic team dedicated to excellence in computer system validation! #CSVEngineer #JobOpening #JoinOurTeam