Validation Engineer II CSV & Compliance (W2 Contract | Locals Only)

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.