CSV Engineer (pharma)

Insight Global; Greenville (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading recruitment firm is seeking a CSV Engineer for a pharmaceutical client in the Greenville, NC area. This role primarily supports sterile manufacturing areas, focusing on the change management program to assess functionality changes and qualify tests. The ideal candidate should have 3-5 years of experience in validation engineering within the pharmaceutical industry and be adept at writing SOPs and coordinating with project workstreams to ensure compliance with FDA regulations.

Qualifications

• 3-5 years of experience as a Validation Analyst or CSV Engineer.
• Experience in the Pharmaceutical Industry as a CSV specialist.
• Thorough experience in writing/reviewing Standard Operating Procedures.

Responsibilities

• Assist in resolving protocol execution issues.
• Support the development of system requirements and specifications.
• Ensure high standard of Computer System Validation.
• Coordinate with various project workstreams.

Skills

Validation Engineering

Risk Based Approach

FDA Regulations

Automation Documentation

Education

Bachelor's Degree in Engineering, IT, or related field

Tools

Allen Bradley Rockwell SCADA

Documentum

Trackwise

Job description

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.

Job Description

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.

Responsibilities

• 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 workstreams 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.