Senior Validation Specialist

Job DescriptionOur 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, 401KWe 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 ResponsibilitiesSupport lifecycle management of IT/OT systems including validation, maintenance, testing, and documentationAuthor, review, and execute validation documents (URS, FRS, IQ, OQ, PQ, risk assessments, periodic reviews)Perform annual maintenance (MILE) activities and system periodic reviewsOwn and manage Quality records including CAPA, Deviations, and Planned EventsConduct audit trail reviews, account reviews, and system compliance checksSupport upgrades, patching, and system changes ensuring GMP complianceCollaborate with global and local stakeholders on validation and compliance activitiesGenerate quality metrics and attend Quality Huddle meetingsMaintain documentation in EDMS platforms (Veeva, Condor, eVal, etc.)Required QualificationsBachelor's degree in Computer Science, Engineering, Life Sciences, or related field5+ years of experience in Computer System Validation (CSV/CSA) within the pharmaceutical or regulated industryStrong knowledge of GAMP, FDA 21 CFR Part 11, Annex 11, GxP, and Data Integrity principlesExperience supporting Level 2 and Level 3 ISA-95 systemsHands-on experience with validation protocol authoring and executionPreferred ExperienceExperience with DeltaV, OSI-PI, MES, SCADA, Siemens Desigo, Rockwell FactoryTalk PharmaSuite, BASUnderstanding of ISA-95 frameworkExperience managing CAPA, Deviations, and Change Control processesIf interested, please send us your updated resume athr@/kavitha@Skill SetAutomation Validation, MES, SCADA

Created: 2026-04-02