CSV/CSA Validation Engineer - Grow as a Design Group Consultant

BW Design Group; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

BW Design Group in the Raleigh-Durham area is seeking a Computer Systems Validation Engineer to plan and execute validation activities for manufacturing and automation systems. You will author validation plans, test cases, protocols, and reports while ensuring compliance with regulatory standards.

The role involves collaborating with engineering, quality, and operations teams, performing risk assessments, and maintaining robust validation documentation.

Qualifications

• Experience in Computer System Validation/Assurance
• Knowledge of CSV/CSA regulatory guidelines (FDA, GxP) is beneficial
• Strong analytical, documentation, and communication skills
• Experience in manufacturing or life sciences is an advantage
• Consulting experience is a plus

Responsibilities

• Plan, develop, and execute computer system validation activities for manufacturing and automation systems.
• Author validation plans, test cases, protocols, and reports.
• Review system requirements and design documents; perform risk assessments.
• Support software and hardware validation efforts and collaborate with cross-functional teams.
• Maintain documentation and continuously improve validation processes and methodologies.

Skills

CSV/CSA knowledge

Validation protocols

Risk-based validation

Documentation

Communication

Education

Bachelor's degree in Engineering/CS/Life Sciences

Job description

BW Design Group in the Raleigh-Durham area is seeking a Computer Systems Validation Engineer to plan and execute validation activities for manufacturing and automation systems. You will author validation plans, test cases, protocols, and reports while ensuring compliance with regulatory standards.

The role involves collaborating with engineering, quality, and operations teams, performing risk assessments, and maintaining robust validation documentation.