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Validation Engineer

Validation Engineer

Technoviz LLCMADISON, WI, US
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Benefits :

  • Competitive salary
  • Opportunity for advancement
  • Training & development

Job Summary

We are seeking a skilled  Validtion Engineer to support validation activities across various IT projects and change control initiatives. The ideal candidate will have a strong foundation in computer systems validation, quality assurance, and regulatory compliance, particularly in pharmaceutical or life sciences environments.

Responsibilities

  • Prepare, review, approve, and manage documentation in the Document Management System (DMS) for system lifecycle deliverables related to projects and change controls, including :

    • Validation Plans & Summary Reports

  • Risk Assessments
  • User Requirements & Functional Specifications
  • Test Plans & Test Scripts (IQ / OQ / PQ)
  • Determine and apply the most effective validation strategy for each project or change activity.
  • Lead and oversee test execution efforts across cross-functional teams, including training, progress tracking, and peer reviews.
  • Develop strong partnerships with business stakeholders to understand operational requirements and ensure validated solutions meet compliance standards.
  • Collaborate with IT teams to maintain consistent adherence to validation protocols and documentation standards.
  • Work closely with Information Systems Quality Assurance (ISQA) to support audits, procedures, and compliance efforts related to IT systems.

    • Qualifications

  • Bachelor's degree or equivalent certification / training.
  • Minimum 2 years of experience in computer systems validation (CSV), change management, and SDLC (Systems Development Life Cycle) methodologies.
  • Deep understanding of CSV principles , SDLC methodologies , and relevant regulatory standards .
  • Familiarity with Computer Software Assurance (CSA) guidelines.
  • Strong written and verbal communication skills, with a focus on Good Documentation Practices (GDP) .
  • Proficiency in :

    • Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, MS Project)

  • Enterprise systems such as SAP , LIMS , or other manufacturing and laboratory applications
  • Veeva Vault
  • ServiceNow
  • Solid understanding of pharmaceutical industry processes (manufacturing, packaging, quality, supply chain).
  • Strong project management awareness and ability to manage tasks within strict timelines, budgets, and compliance frameworks.
  • Effective interpersonal and conflict resolution skills; ability to thrive in dynamic, fast-paced environments with minimal supervision.

    • This is a remote position.

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    Validation Engineer • MADISON, WI, US