Senior Computer Systems Validation Specialist

Job description

Position Title: Sr. Computer Systems Validation Specialist (R000000) Position Location: 1101 Hamlin Road, Durham, NC 27704 Days / Hours: Mon – Fri / 9:00 a.m. – 5:00 p.m. Summary of Duties: Support all aspects of the Computer Systems Validation (CSV) Lifecycle. Complete the execution and documentation of the CSV Program at the Durham facility. This includes all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews. Ensure project deadlines and performance standards for the CSV team are met while communicating status accordingly. Respond to inquiries from management, end users and clients, and provide status updates on a frequent basis. Plan, contribute and collaborate on CSV activities for lab and manufacturing systems. Keep current of trends, new products and technologies, and regulatory requirements that may have an impact on CSV. Participate in regulatory and client audits as needed. Testing of computer systems in the field including lab, manufacturing, and automation systems. Handwritte...