CSV Validation Engineer – Kneat Expert (GxP)

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

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