Senior Validation Engineer

Job Title:
Validation Engineer II – CSV & Compliance Support

Job Duration: 12 months contract with possible ext

Job Location:
Hillsboro, Oregon

The Validation Engineer II will support Computer System Validation (CSV) and compliance activities for regulated IT/OT manufacturing systems
. This role partners with ITOT System Owners to ensure systems remain compliant, validated, and aligned with GMP and global validation standards. Systems supported will primarily fall under ISA-95 Level 2 and Level 3.

• Support ITOT System Owners with system lifecycle activities including maintenance, validation, documentation, and testing.
• Develop, update, and maintain validation and lifecycle documentation for ITOT systems including Delta
  
  V, PI, MES, SCADA, Lyo Plus, FIT, BAS, and WAGIT
  .
• Perform annual maintenance activities (MILE), including creation, execution, and review of installation and test protocols.
• Manage and drive closure of QMS records such as CAPA, deviations, and planned events
  .
• Conduct periodic system reviews by analyzing deviation history and system events over the past three years and preparing compliance reports.
• Support validation planning and execution, including generation, approval, and execution of validation protocols.
• Assist with system maintenance activities including audit trail reviews and user account audits.
• Support system upgrades, patching, and change activities to ensure continued GMP compliance
  .
• Generate compliance and validation reports as requested.
• Support document management platforms including Veeva, Condor, and eVal Roche
  .
• Provide administrative support including document formatting and routing.
• Collaborate with local and global stakeholders to ensure timely completion of validation and compliance deliverables.
• Participate in Quality Huddles and provide quality metrics in alignment with global validation policies.

• Bachelor’s degree in Computer Science, Engineering, Life Sciences
  , or a related field.
• 5+ years of experience in Computer System Validation frameworks such as CSV/CSA and GAMP
  , preferably within the pharmaceutical or regulated life sciences industry.
• Strong understanding of ISA-95 with hands‑on experience supporting Level 2 and Level 3 systems (required).
• Knowledge of regulatory and compliance requirements including:
• 21 CFR Part 11
• Annex 11
• EU GMP Annex 1
• GxP practices
• Data Integrity principles
• Strong understanding of system/data integrity risk assessment concepts.

• Experience with manufacturing automation and IT/OT systems such as:
• SCADA
• OSI-PI
• Rockwell Factory Talk Pharma Suite
• MES / E  systems
• Experience with systems administration, E  recipe authoring, or software development exposure.
• Experience with ISA-95 Level 1 systems is a plus.