Labware LIMS CSV EngineerWe are looking for a Labware LIMS CSV engineer with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.ResponsibilitiesDevelop Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)Develop Validation testing strategy in accordance with Gilead's policy and proceduresWorking closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projectsAssist with understanding the business requirements, analyze and suggest technical solution for LIMS projectsWork closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS applicationCreate, review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projectsQualification protocols execution and final report view and approval for LIMS projectsPartner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projectsLearn and become proficient the EDMS (Electronic Data Management System), for document review and approval and ELMS (Electronic Leaning Management System) for documenting and performing assigned training.Prepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:Standard Operating Procedures (SOPs)Work Instructions (WIs)FormsUser Manuals / User Guides / User References / Quick Reference Guides and Training MaterialTraining PlansReference DocumentsSpecificationsReportsWork independently but recognize the need to consult stake holders and keep them informed of progress.Required Experience / Skills:Minimum of 3-5 years of experience working on a Labware LIMS application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.Advanced knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.Ability to master technical content through interaction with subject matter experts.Effective communication and interpersonal skills.Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.Understanding of programming and relational database concepts is required.Required Education:BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.
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