Senior Validation Specialist

Dawar Consulting•Hillsboro, OR

About The Position

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.

Requirements

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

Nice To Haves

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

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.)