Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting services as well as prepackaged, industry specific solutions and services to companies around the world. Our Consulting Services are dedicated to helping our clients maximize their investments in IT and the overall effectiveness and efficiency of the business. Tranzeal s deep industry experience makes us the partner of choice for a growing number of Fortune 1000 companies, midsize enterprises and small businesses worldwide.
We are currently looking for 'Validation Engineer II – CSV & Compliance (W2 Contract | Locals Only)' to support one of our clients with the following skills:
Validation Engineer II – CSV & Compliance (W2 Contract | Locals Only)
Location: Hillsboro, OR (Onsite only)
Duration: 12+ Months
Rate: doe
We 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. This role partners closely with System Owners, Quality, and Global teams to ensure systems remain in a validated and compliant state throughout their lifecycle.
Key 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
Must-Have Skills
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)
Interested candidates, Please share your resumes to
The national base pay range below is a good-faith estimate of what our client may pay for new hires. Actual pay may vary based on Client's assessment of the candidates knowledge, skills, abilities (KSAs), related experience, education, certifications and ability to meet required minimum job qualifications. Other factors impacting pay include prevailing wages in the work location and internal equity. $70 - $80 per hour on W2.