Lab It Administrator

Role Description:LabITAdministrator role whose primary responsibility will be to work withLabCOE and local site DMO team to provide end-to-end support for the Business users & Stakeholders, Coordinate with Site for technical topics, Coordinate with Support team, etc..Role Functions(Functions include, but are not limited to, the following):As a Lab IT Administrator, you are responsible for providing hands-on end-user support, administration, and issue resolution for GxP-controlled laboratory equipment, servers, desktops, and software packages.Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.Execute routine system administration and maintenance activities as required.Ensure proper user management process is adhered to for all computerised systemsAdminister lab system access requestsAuthor the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.Assist systems users with defining, authoring, and documenting system use in user, admin, and maintenance SOPsEnsures systems comply with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annexe 11 and all Data Integrity standards and guidelines.Ensure applicable standards and specifications are adhered to.Work closely with CSV Lead, System Integrator and Site IT Team.Work with the operational readiness team and operations to ensure acceptable turnover.Provide support during internal and agency inspections.Support subject matter expert (SME) for general troubleshooting, problem solving, technical direction and guidance to support overall business needsTake ownership of related tasks, work under minimal supervision, utilise the industry experience and best judgment to make tactical decisions, stay proactive, etc.Advanced knowledge of system vulnerabilities and security issues.Monitor the system daily and respond immediately to security or usability concerns.Create and verify backups of dataRespond to and resolve help desk requestsQualifications & Education:Bachelor's Degree or Higher in a technical discipline5+ years of professional experience in the digital spaceExcellent communication skills (written and oral).Ability to multitask and handle tasks with competing priorities effectively.Experience identifying operational issues and recommending and implementing strategies to resolve problemsDesired Qualifications:At least 3 years of experience working in a similar position within a GxP-regulated environmentSpecific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems is required, including the authoring of end-to-end of life cycle documents (including systems use and administration procedures)An understanding of Data Integrity concepts is requiredExcellent communication and written skills required