Validation Engineer

40 Days Old

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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Location:
Madison
Salary:
$35 per hour
Category:
Manufacturing

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