logo

View all jobs

Lead Labware LIMS Validation/Business Process Consultant

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

Type of role: Contract: 12-24+ months 

Location: Foster City, CA 94404
 
Lead Computer System Validation/Business Process Analyst
We are looking for a Labware LIMS CSV engineer with GMP experience in LIMS business processes, and in the creation, review and approval of CSV deliverables for laboratory informatics implementation projects.
 
Responsibilities
  • Develop Process mapping and Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)
  • Develop Validation standardization strategy globally for LIMS in accordance with corporate policy and procedures
  • Working closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS Best Practices.
  • Assist with understanding the business requirements, analyze and suggest technical solution for LIMS processes and 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
  • 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
  • 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
AdeptSource
 
Powered by