Computer Systems Validation Engineer in Hillsboro

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Job Description

We are seeking an experienced IT/OT Computer Systems Validation (CSV) Engineer to support regulated manufacturing systems within a GMP pharmaceutical environment. This role partners closely with system owners to manage the full lifecycle of Level 2–3 ISA-95 systems, ensuring compliance, validation, and ongoing operational readiness.

The ideal candidate brings strong CSV/CSA expertise, hands-on experience with manufacturing and automation systems, and a solid understanding of FDA and global regulatory requirements.

Key Responsibilities

• Support validation, maintenance, and lifecycle activities for IT/OT manufacturing systems (Level 2–3).
• Create, execute, and maintain CSV documentation (protocols, reports, periodic reviews).
• Own QMS records including deviations, CAPAs, and planned events.
• Collaborate with system owners and global stakeholders to ensure GMP and data integrity compliance.

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