Tranzeal Incorporated · 1 day ago
Validation Engineer II – CSV & Compliance (W2 Contract | Locals Only)
Hillsboro, OR
Contract
Onsite
Senior Level
$70/hr - $80/hr
5+ years expTranzeal Incorporated is an industry leading global Business Transformation Service Provider that offers consulting services and specific solutions to enhance business effectiveness. They are currently 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
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
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.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Neha Varma
Associate Director- Client Partner
Sheehan Khera
Client Partner
Company data provided by crunchbase