Validation Engineer

Technoviz LLC; Madison (WI); Remote; USD 70,000 - 100,000; Full time

Job summary

Une entreprise dynamique cherche un Validation Engineer pour soutenir les activités de validation dans divers projets informatiques. Le candidat idéal doit avoir une solide base en validation des systèmes informatiques et en assurance qualité, ainsi qu'une connaissance des environnements réglementaires liés aux sciences de la vie. Les responsabilités incluent la gestion de la documentation et la collaboration avec des équipes interfonctionnelles pour assurer la conformité.

Benefits

Salaire compétitif

Opportunité d'avancement

Formation et développement

Qualifications

• Expérience minimale de 2 ans en validation des systèmes informatiques.
• Compréhension approfondie des principes CSV et SDLC.
• Familiarité avec les directives CSA et les normes réglementaires pertinentes.

Responsibilities

• Préparer, examiner et approuver la documentation pour les livrables du cycle de vie du système.
• Déterminer et appliquer la stratégie de validation la plus efficace.
• Collaborer avec les équipes IT pour assurer le respect des normes de validation.

Skills

Communication écrite et verbale

Documentation conforme aux bonnes pratiques

Gestion de projet

Compétences interpersonnelles

Education

Baccalauréat ou certification équivalente

Tools

Microsoft Office Suite

SAP

LIMS

Veeva Vault

ServiceNow

Job description

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.