Validation Engineer - Lab and Computer Systems
Edison-New Brunswick Metro Area, New Jersey
- Support Computer System Validation Projects and Equipment Qualifications which support Lab Operations:
- Support the implementation and validation activities of new and upgrades to laboratory software and instrumentation.
- These activities include technical analysis and design; executing, testing, developing validation deliverables and managing change requests. Address technical and compliance challenges in all phases of the System Validation Lifecycle; research, test, and generate solutions and mitigations. Experience with temperature mapping, Kaye Validators, Flow Cytometry, and Particle Size Analyzers is a plus.
- Technical Support: Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis, execution and approval of IQ, OQ, PQ, PV, and UAT protocols and reports, and perform technical reviews of validation deliverables.
- Develop technical support manuals and provide technical input to address system troubleshooting and administration post system release. Be able to quickly learn and configure new applications, system architecture, and instrumentation with or without vendor assistance and training.
- Must be familiar with different modes of communication between computer and instrumentation it interacts with (TCP/IP, local networks, static vs. dynamic, RS232 configuration). System Administration and technical support experience a plus.
Documentation: Create Technical Support Manuals for all new GMP systems. Develop, review and approve validation/qualification deliverables such as Validation Plans, Requirements Specifications, Configuration Specifications, Traceability Matrices, Summary Reports, Change Controls.