**Role & seniority: ** Validation (CSV) Engineer (GxP computerized systems); seniority not specified (qualification-focused; likely mid-level)

**Stack/tools: **

Kneat (required)
Microsoft Office (strong skills)
CSV/validation documentation tools and document/change management systems
Top 3 responsibilities:
- Execute new system validations and updates under change control; review validation/test plans and support test execution
- Create and manage CSV validation deliverables (e.g., requirements, traceability matrices, test cases)
- Ensure deliverables align with corporate quality standards/templates; support document management and validated state tracking/communication
Must-have skills:
- Experience with CSV/validation documentation and lifecycle management in a regulated pharmaceutical (GxP) environment
- Kneat experience (required)
- Strong attention to detail; excellent communication and organizational skills
Nice-to-haves:
- Exposure to control systems, CSV, and Commissioning & Qualification (CQ/ C&Q)
- Supporting change control, periodic reviews, and access/security processes
- CSV process improvement and automation delivery experience
Location & work type: Onsite, Lebanon, IN; full-time (US work authorization required; sponsorship not provided)

Full Description

Overview

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.

Onsite - Lebanon, IN

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.