Our client, a world leader in diagnostics
and life sciences, is looking for a
"

Senior

Validation Specialist” based out of Hillsboro,
OR.

Job Duration:
Long term Contract (Possibility Of
Further Extension)

Company Benefits: Medical, Dental,
Vision, Paid Sick leave, 401K

We are seeking an experienced IT/OT Computer System Validation (CSV) Engineer to support lifecycle management, validation, and compliance activities for GMP-regulated manufacturing systems. This role will work closely with System Owners to ensure validated state, data integrity, and regulatory compliance for Level 2 and Level 3 ISA-95 systems.

Key Responsibilities

• 
  Support lifecycle management of IT/OT systems including validation, maintenance, testing, and documentation

• 
  Author, review, and execute validation documents (URS, FRS, IQ, OQ, PQ, risk assessments, periodic reviews)

• 
  Perform annual maintenance (MILE) activities and system periodic reviews

• 
  Own and manage Quality records including CAPA, Deviations, and Planned Events

• 
  Conduct audit trail reviews, account reviews, and system compliance checks

• 
  Support upgrades, patching, and system changes ensuring GMP compliance

• 
  Collaborate with global and local stakeholders on validation and compliance activities

• 
  Generate quality metrics and attend Quality Huddle meetings

• 
  Maintain documentation in EDMS platforms (Veeva, Condor, eVal, etc.)

Required Qualifications

• 
  Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field

• 
  5+ years of experience in Computer System Validation (CSV/CSA) within the pharmaceutical or regulated industry

• 
  Strong knowledge of GAMP, FDA 21 CFR Part 11, Annex 11, GxP, and Data Integrity principles

• 
  Experience supporting Level 2 and Level 3 ISA-95 systems

• 
  Hands-on experience with validation protocol authoring and execution

Preferred Experience

• 
  Experience with DeltaV, OSI-PI, MES, SCADA, Siemens Desigo, Rockwell FactoryTalk PharmaSuite, BAS

• 
  Understanding of ISA-95 framework

• 
  Experience managing CAPA, Deviations, and Change Control processes

If interested, please send us your updated
resume at

hr@dawarconsulting.com
/
kavitha@dawarconsulting.com