Sr. Validation Engineer
Newark Metro Area, NJ
Responsibilities include, but are not limited to, the following:
1. 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.
2. 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, 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.
3. Develop, review and approve validation/qualification deliverables such as Validation Plans, Requirements Specifications, Configuration Specifications, Traceability Matrices, Summary Reports, Change Controls.
4. Communication: Effectively communicate the status of all validation/qualification projects to management and to all affected stakeholders. Keeps track of lessons learned and shares those lessons with team members. Work with the Business on gathering analytical requirements. Ensure requirements are feasible and testable. Take on a role of a project manager, coordinate vendors, end users, IT, and other parties as needed to successfully complete projects based on agreed upon timelines.
BA/BS in IT/Engineering discipline or Life Sciences with experience working in IT/technology roles
5+ years experience in FDA-regulated industry
7-10 years experience in equipment qualification
Strong instrumentation and computer system validation background and experience in laboratory operations
Excellent knowledge of cGMP in the pharmaceutical/biotechnology industry