Scalence L.L.C. · 1 month ago
Computer Systems Validation Engineer
Bothell, WA
Full-time
Hybrid
Mid, Senior Level
$75/hr - $76.61/hr
4+ years expScalence L.L.C. is seeking a Computer Systems Validation Engineer to work cross-functionally in leading and executing validation activities for GxP electronic systems and applications. The role involves partnering with Business Owners and Technical Owners to create and manage validation deliverables, ensuring compliance with relevant regulations throughout the validation lifecycle.
Information Technology & Services
Responsibilities
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
Other related duties as assigned
Qualification
Required
Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement)
4+ years of direct experience with CSV activities
Strong knowledge of GAMP / risk-based approaches to validation
Good understanding of electronic records and signatures
Strong knowledge on Manufacturing Execution System (MES) validation
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.)
Ability to effectively communicate with both technical and non-technical team members
Strong interpersonal skills, especially regarding teamwork, client focus, verbal and written communication
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)
Strong technical and problem-solving skills and the ability to work independently
Demonstrated success working in a high-performing, business results-driven environment
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)
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase