Validation Engineer

TECHNOVIZ LLC; Madison (WI); Remote; USD 65,000 - 85,000; Full time

Job summary

A leading company is seeking a Validation Engineer to support validation activities across IT projects and change control initiatives. The successful candidate will have a thorough understanding of computer systems validation and regulatory compliance within the pharmaceutical or life sciences sectors. This remote position offers opportunities for advancement and professional development, along with competitive benefits.

Benefits

Competitive salary

Opportunity for advancement

Training & development

Qualifications

• Minimum 2 years of experience in computer systems validation (CSV).
• Familiarity with Computer Software Assurance (CSA) guidelines.
• Strong written and verbal communication skills.

Responsibilities

• Prepare and manage documentation in DMS for validation lifecycle deliverables.
• Lead test execution efforts and oversee peer reviews.
• Collaborate with stakeholders to ensure compliance with validation standards.

Skills

Communication

Documentation

Project Management

Education

Bachelor's degree or equivalent certification/training

Tools

Microsoft Office Suite

SAP

LIMS

Veeva Vault

ServiceNow

Job description

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Job Summary

We are seeking a skilled Validation 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.

Benefits:

• Competitive salary
• Opportunity for advancement
• Training & development

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.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Quality Assurance