Computer System Validation Engineer Job at TSR Consulting, Bothell, WA

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  • TSR Consulting
  • Bothell, WA

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)

Job Tags

Local area, 3 days per week,

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