Tranzeal Incorporated · 1 day ago
Validation Engineer II – CSV & Compliance Support
Hillsboro, OR
Contract
Onsite
Senior Level, Lead/Staff
8+ years expTranzeal Incorporated is seeking a Validation Engineer II to support IT/OT System Owners in maintaining, validating, testing, and documenting systems to ensure compliance and readiness for inspections. The role involves managing documentation, supporting audits, and collaborating with global stakeholders to maintain system integrity and compliance.
Big DataBusiness IntelligenceCloud InfrastructureInfrastructureMachine Learning
Responsibilities
Create, update, and execute CSV lifecycle documentation for IT/OT systems (e.g., DeltaV, PI, MES, SCADA, BAS) within ISA-95 Level 2–3 environments
Support annual maintenance (MILE) activities: installation and test protocols, reviews, and execution
Manage QMS records (CAPA, Deviations, Planned Events) and drive closure
Conduct periodic system reviews and validated state assessments
Assist with validation protocols (authoring, approval, execution)
Support audits, account reviews, audit trails, and system reporting
Partner on system upgrades/patching to maintain GMP compliance
Support document management systems (Veeva, Condor, eVal) and admin tasks
Collaborate with global stakeholders and provide quality metrics
Qualification
Required
BS in Computer Science, Engineering, Life Sciences, or related field
8+ years in Computer System Validation (CSV/CSA, GAMP), preferably pharma
Experience with Level 2–3 systems (ISA-95); Level 1 a plus
Familiarity with SCADA, OSI-PI, DeltaV, MES, Siemens Desigo, FactoryTalk, etc
Knowledge of FDA 21 CFR Part 11, Annex 11, EU GMP, GxP, and data integrity principles
Understanding of system/data integrity risk assessments
Company
Tranzeal Incorporated
Tranzeal is an industry leading global Business Transformation Service Provider.
201-500 employees
H1B Sponsorship
Tranzeal Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (4)
2022 (6)
2021 (7)
2020 (15)
Funding
Current Stage
Growth StageLeadership Team
Neha Varma
Associate Director- Client Partner
Sheehan Khera
Client Partner
Company data provided by crunchbase