Computer System Validation Engineer

Job Title:  ITOT Computer System Validation Engineer
Job Location: 4625 NE Brookwood Parkway, Hillsboro, OR 97124
Duration: 1 Year contract with possibility for extension or conversion
Payrate: $70.00 - $80.00 per hr. on W2

Job Description:
We are seeking an ITOT Computer System Validation Engineer to support daily operations of manufacturing IT/OT systems within a highly automated pharmaceutical facility. This role will be responsible for validation, compliance, and inspection readiness of systems, while contributing to digital transformation and technology standardization initiatives.

Key Responsibilities

• Review and maintain validation documentation (plans, reports, test cases).
• Ensure compliance with CSV SOPs, ALCOA+ principles, and regulatory guidelines (21 CFR Part 11, Annex 11, GxP).
• Support audits/inspections as a CSV subject matter expert.
• Investigate deviations, define CAPAs, and maintain validated state of systems.
• Collaborate with global and local stakeholders on validation and compliance activities.
• Contribute to manufacturing projects and system enhancements.

Qualifications

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field.
• 6+ years of experience in IT, OT, Quality Systems, or Validation (CSV/CSA, GAMP) within a regulated industry.
• Strong understanding of ISA-95 model (Level 2 & 3 systems required; Level 1 preferred).
• Knowledge of FDA regulations, EU GMP Annex 1, and Data Integrity principles.
• Experience with risk assessment, system administration, MES systems, and manufacturing controls is a plus.
• Familiarity with tools such as Veeva, HP ALM, Valgenesis, ServiceNow is an advantage.

What We’re Looking For

• Strong communication and documentation skills.
• Ability to work cross-functionally in agile teams.
• Results-driven with a proactive, innovative mindset.
• Knowledge of trends in Smart Manufacturing, IoT, Pharma 4.0, and Cybersecurity.