Senior Validation Specialist

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

[email protected]/[email protected]