CSV Engineer; pharma

Qualifications

• Bachelor's Degree in Engineering, IT, or related field
• 3-5 years of experience working as a Validation Analyst or CQV/CSV Engineer in GxP environments and preferably has at least 3 years of experience in the Pharmaceutical Industry as a CSV specialist or engineer.
• Experience in using Risk Based approach to validate configured and custom developed systems.
• Excellent experience in validating wide variety of applications and infrastructure - Allen Bradley Rockwell SCADA systems, manufacturing PLCs, distributed control systems, Electronic Document management System (Documentum), Trackwise.
• Thorough experience in writing/reviewing/revising Standard Operating Procedures (SOPs) to ensure they meet FDA regulations.

Insight Global is looking for a CSV Engineer for a pharmaceutical client in the Greenville, NC area. The CSV Engineer will primarily support the sterile manufacturing areas and work with the change management program to assess functionality changes and design tests to qualify these changes for the entire site.

• Assist in resolving protocol execution issues using critical analysis and develop sound, reasonable solutions.
• Assist with the development of system requirements and specifications to ensure requirements are testable and meet 21 CFR Part 11.
• Support generation of Validation documents.
• Review and approve Automation documentation including risk and impact assessments, computer systems validation plans, user requirements s
• Specifications, functional requirement specifications, traceability matrices, release reports, and all documents and deliverables within the scope of the Automation Master Validation Plan as needed.
• Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time suiting the company's vision and objectives
• Coordinate with various project work streams including Automation, Automation System vendor(s), CSV, CQV, Utilities, Process Engineering, and others as needed.
• Attend regularly scheduled project status meetings as needed.
• Complete Safety, Project Procedure, and Project Instruction training as required.