Computer System Validation Engineer

**Local candidates to Bothell WA ONLY **MUST have Manufacturing Execution Systems (MES) 83861 TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical company is hiring a Computer System Validation Engineer for a 6+ months hybrid contracting assignment. Must have skills: Strong Computer Systems Validation (CSV) experience, Manufacturing Execution Systems (MES), Protocol drafting and execution 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.) Pay: $74-75/hour W2 Location: Bothell WA Hybrid (3 days a week onsite) and required to be onsite throughout UAT execution Responsibilities: Works cross-functionally to lead and execute validation activities for GxP electronic systems and applications Primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with procedures and regulations Author, review and/or approve applicable CSV documentation Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow) Knowledge and exposure to Business Quality Management Systems (i.e. Veeva) Understanding of computer system validation Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch) Pay: $74.00 - $75.00 per hour Benefits: 401(k) Dental insurance Health insurance Work Location: In person