Validation Engineer

Process Alliance; Lebanon (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Process Alliance is hiring a Validation (CSV) Engineer to support validation and lifecycle management of GxP computerized systems in a regulated pharmaceutical environment. You will develop and execute validation documentation to ensure compliance with quality standards and regulatory requirements.

Key responsibilities include executing validation activities under change control, managing CSV documents, and collaborating with QA and cross-functional teams to ensure timely, compliant validation

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, reviewing validation/test plans.
• Generate, edit, and manage CSV documentation (requirements, traceability matrices, test cases).
• Ensure validation deliverables align with 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 compliant execution of validation activities.
• Contribute to continuous improvement of CSV processes and automation delivery.

Skills

Kneat experience

Microsoft Office

Detail-oriented

Excellent communication

Education

BS in Engineering

MS in Engineering

Tools

Kneat

Document management systems

Job description

We’re hiring a 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

**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.

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.