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Tranzeal Incorporated · 4 hours ago

Validation Engineer II – CSV & Compliance

Hillsboro, OR

Contract

Onsite

Senior Level

$70/hr - $80/hr

5+ years exp

Tranzeal Incorporated is a leading global Business Transformation Service Provider focused on maximizing IT investments and improving business efficiency. They are seeking a Validation Engineer II to support Computer System Validation (CSV) and GMP compliance for critical IT/OT manufacturing systems in a regulated pharma environment.

Big DataBusiness IntelligenceCloud InfrastructureInfrastructureMachine Learning

Growth Opportunities

No H1B

Hiring Manager

Venkata Suresh

Responsibilities

Execute and maintain CSV lifecycle activities including documentation, testing, reviews, and maintenance

Support Level 2 & Level 3 IT/OT systems (DeltaV, PI, MES, SCADA, BAS, etc.) aligned with ISA-95

Create, update, execute, and review validation protocols and reports

Perform periodic system reviews, audit trail reviews, and annual maintenance (MILE) activities

Manage Quality records (CAPA, Deviations, Planned Events) to closure

Support system upgrades, patching, and changes while ensuring GMP compliance

Collaborate with local and global stakeholders and provide quality metrics and reporting

Qualification

Computer System ValidationGAMP methodologyFDA 21 CFR Part 11ISA-95 Level 2 & 3 systemsQuality Management System recordsBachelor’s degreeCollaboration skills

Required

Bachelor's degree in Computer Science, Engineering, Life Sciences, or equivalent

5+ years of hands-on Computer System Validation (CSV/CSA) experience in regulated industries

Strong working knowledge of GAMP and validation lifecycle methodology

Experience with ISA-95 Level 2 & Level 3 systems

Solid understanding of FDA 21 CFR Part 11, EU GMP, Annex 11, GxP, and Data Integrity principles

Hands-on experience creating and executing validation documentation and protocols

Experience managing Quality Management System records (CAPA, Deviations, Planned Events)

Ability to work onsite in Hillsboro, OR (no relocation)

Company

Tranzeal Incorporated

Tranzeal is an industry leading global Business Transformation Service Provider.

San Jose, California, USA

201-500 employees

https://www.tranzeal.com/

Funding

Current Stage

Growth Stage

Leadership Team

Neha Varma

Associate Director- Client Partner

Sheehan Khera

Client Partner

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