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Computer Systems Validation (CSV) Engineer
Durham, NC 27713 United States
Under the supervision of the Validation Manager, this position will serve as a member of the Quality Assurance/Validation team supporting (currently) five biopharmaceutical manufacturing facilities in the U.S. and Canada. Based in the RTP area of North Carolina, the CSV Engineer has primary responsibility for driving overall quality performance and compliance throughout the global organization by defining, implementing and maintaining the validation program for computer systems and automated equipment and utility systems. The CSV engineer will provide compliance guidance for GxP and Non-GxP software releases.
• Work with Business, System and Equipment Owners on validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Installation Qualification, Operational Qualification and Preventative Qualification Protocols, Reports, and Standard Operating Procedures.
• Managing Vendor Validation Documentation.
• Test Execution and Deviation Management.
• Planning and scheduling of validation and Validation Lifecycle deliverables.
• Review existing CSV reports and identifies gaps for GMP, and regulatory compliance.
• Coordinate with end users and process owners to resolve any identified issues to bring validation to acceptable levels.
• Participate in project management meetings as Validation representative determining CSV requirements as needed.
• Identify areas and opportunities to improve CSV Program.
• Provide consultation to other departments performing CSV activities.
• Ensure validation program meets requirements of FDA 21 CFR Part 11 and Eudralex Volume 4 Annex 11 requirements.
- Proficiency with GAMP 5, FDA 21 CFR Part 11, and Eudralex Volume 4 Annex 11
- Exceptional written and verbal communication skills
- Ability to plan and schedule completion of Validation Lifecycle deliverables with little supervision
- Ability to anticipate problems/issues and create contingency plans
- Business acumen required to evaluate technical priorities and tasks against business and budgetary constraints
- Demonstrated success working through language and cultural differences
- Aptitude to quickly understand various IT and Pharmaceutical disciplines at a moderately complex level
- 3+ years of validation experience.
- Experience working in a GxP Life Sciences environment for Computer Systems Validation (CSV).
- Experience working with automated equipment and utility systems.
- Experience with GAMP5, 21 CFR Part 11 and Annex 11
- Excellent verbal and written communication skills.
- Project Management experience
- French Fluency is a plus
Bachelor’s degree in Life Sciences, Information Systems, Engineering or minimum 9 years of applicable experience.
10 to 15 percent travel may be required.
North Carolina Biotechnology Center