Lab Systems Validation - Part 11 Analytical
Newark Metro Area, New Jersey
- Support Computer System Validation Projects and Lab Equipment Qualifications such as HPLC and related instruments and software
- 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.
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). Experience with relational databases 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.
. 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 and 21 CFR Part11 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 computer automation/validation
Strong instrumentation and computer system validation background and experience in laboratory operations
Excellent knowledge of cGMP in the pharmaceutical/biotechnology industry
Excellent computer skills
Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required