Job title: Computer System Validation Engineer
Location: Bothell, WA* Hybrid (no relocation assistance provided).
Job ID # 80468
Rate type: W2 only
Top Skills:
• Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
• Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
• Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.
PURPOSE AND SCOPE OF POSITION:
The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant BMS procedures and regulations. This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.
DUTIES AND RESPONSIBILITIES:
• Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
• 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
• Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required)
• Other related duties as assigned
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
• Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
• Ability to effectively communicate with both technical and non-technical team members.
• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
• Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.
• Knowledge of IT service management platforms to support change IT operational events (i.e. ServiceNow).
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
Education and Experience:
• Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.
• Must have experience with Computer system validation of MES.
• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
