Validation Engineer (Computer System Validation)

We are seeking a Validation Engineer to support validation activities within a GMP biotechnology environment. In this role, you will partner closely with IT/OT system owners to manage the full lifecycle of computer systems, including maintenance, validation, documentation, and testing. This is a 12‑month contract based onsite five days a week in Hillsboro, Oregon, offering the opportunity to contribute to critical system reliability and compliance efforts. Responsibilities Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model. Help perform MILE (annual system maintenance) activities for ITOT Systems. For example, create, update, execute, or review installation protocols, test protocols, etc. Own Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed. Perform system periodic reviews; This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports. Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems. Support validation activities, generation, approval and execution of validation protocols. Assist System Owners in system maintenance activities such as Periodic System Audit Trail Review, account audits, etc. Creating reports for various systems on demand. Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance. Support on documents management systems (Veeva, Condor). Support the team with administrative tasks, such as document formatting, document routing. Qualifications Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field. Minimum 5 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry. Knowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development. Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus. Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles. Good understanding of system and data integrity risk assessment concepts. $156,894-$196,123 Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance – PPO, HMO & HSA 401k plan Employee Assistance Program Long-term disability Weekly payroll Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. #J-18808-Ljbffr