CSV Engineer – GxP Systems Validation | Kneat Expert

Process Alliance; Indianapolis (IN); On-site; USD 85,000 - 115,000; Full time

Job summary

Process Alliance is seeking a Computer System Validation (CSV) Engineer to support validation of GxP computerized systems in a regulated pharmaceutical setting.

The role emphasizes compliance with quality standards and regulatory requirements, developing and executing validation documentation, and collaborating with QA, SMEs, and cross-functional teams to drive timely validation activities and continuous improvement.

Qualifications

• BS or MS in Engineering preferred.
• Kneat experience required.
• Exposure to Control Systems, CSV, and Commissioning & Qualification preferred.
• Strong Microsoft Office skills and experience with document/change management systems.
• Detail-oriented with excellent communication and organizational skills.

Responsibilities

• Execute new system validation and updates under change management, including reviewing validation/test plans and supporting test execution
• Generate, edit, and manage CSV documentation such as requirements, traceability matrices, and test cases
• Ensure all validation deliverables align with corporate quality standards, templates, and document management practices
• Support change control documentation, periodic review activities, and system access/security processes
• Maintain validated state of systems by tracking, reporting, and communicating document status
• Collaborate with SMEs, Quality Assurance, and cross-functional teams to ensure timely and compliant execution of validation activities
• Contribute to continuous improvement of CSV processes and automation delivery

Skills

Communication

Detail-oriented

Education

BS or MS in Engineering

Tools

Kneat

Microsoft Office

Document management systems

Job description

Process Alliance is seeking a Computer System Validation (CSV) Engineer to support validation of GxP computerized systems in a regulated pharmaceutical setting.

The role emphasizes compliance with quality standards and regulatory requirements, developing and executing validation documentation, and collaborating with QA, SMEs, and cross-functional teams to drive timely validation activities and continuous improvement.