Computer System Validation (CSV) Engineer

We’re hiring a Computer System Validation (CSV) Engineer to support validation and lifecycle management of GxP computerized systems in a regulated pharmaceutical environment. This role focuses on ensuring compliance with corporate quality standards and applicable regulatory requirements through the development and execution of validation documentation.

• 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

• 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

At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.

Visit our website at  to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.

** Qualified applicants must be authorized to work in the United States on a full-time basis. Process Alliance will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.**