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Validation Engineer (Indianapolis)

Validation Engineer (Indianapolis)

Process AllianceIndianapolis, IN, US
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Job Title : Validation Engineer

Location : On-Site

Overview :

Were hiring a Validation Engineer to support Computer System Validation (CSV) and system qualification activities in a regulated pharmaceutical environment. This role is ideal for someone with strong documentation skills and experience working with electronic systems, validation deliverables, and change management processes. Youll be responsible for ensuring compliance with corporate quality standards while supporting automation and system delivery.

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.

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