Computer System Validation (CSV) Engineer

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

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.

Key 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

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

About Our Culture:

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.

Learn more about us:

Visit our website at www.processalliance.com 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.**