Senior Validation Specialist
Dawar Consulting
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 View email address on click.appcast.io/View email address on click.appcast.io #J-18808-Ljbffr
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