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Senior Validation Specialist
Job in
Hillsboro, Washington County, Oregon, 97104, USA
Listed on 2026-02-16
Listing for:
Dawar Consulting
Full Time
position Listed on 2026-02-16
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
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.)
- 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
- Experience with Delta
V, OSI-PI, MES, SCADA, Siemens Desigo, Rockwell Factory Talk Pharma Suite, BAS - Understanding of ISA-95 framework
- Experience managing CAPA, Deviations, and Change Control processes
If interested, please send us your updated resume at
#J-18808-Ljbffr
Position Requirements
10+ Years
work experience
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