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Lead Labware LIMS Validation Consultant

Foster City, CA · Biotech/Pharmaceutical
Title: Lead Labware LIMS Validation Consultant

Type of role: Contract: 12-24+ months 

Location: Foster City, CA 94404
Lead Computer System Validation Engineer
We are looking for a Labware LIMS CSV engineer with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.
  • Develop Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)
  • Develop Validation testing strategy in accordance with Gilead’s policy and procedures
  • Working closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projects
  • Assist with understanding the business requirements, analyze and suggest technical solution for LIMS projects
  • Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS application
  • Create, review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projects
  • Qualification protocols execution and final report view and approval for LIMS projects
  • Partner 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 projects
  • Learn 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)
    • Forms
    • User Manuals / User Guides / User References / Quick Reference Guides and Training Material
    • Training Plans
    • Reference Documents
    • Specifications
    • Reports
  • Work 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 11 requirements. 
  • 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.
Dawn West
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