Job Description

**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)

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