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,