Computer System Validation Specialist

3 weeks ago


Foster City, California, United States TechnoGen Full time

We are seeking a highly skilled Computer System Validation Lead to join our team at TechnoGen. As a CSV Lead, you will be responsible for improving the effectiveness and efficiency of our CSV delivery model through the creation of various templates, training courses, and the periodic collection of KPI metrics.

Key responsibilities include providing thought leadership for GMP Systems, working across different departments to deliver CSV-related programs, innovations, and communications. You will also contribute to operational and process improvement initiatives related to Quality and Compliance.

As a CSV expert, you will apply your knowledge to make a major contribution to a specific business unit or department. You will interpret and execute company policies and procedures, recommending modifications to operating policies as needed.

Key qualifications include a minimum of 10+ years of experience working in the CSV field and GMP Pharmaceutical / Biotechnology / Medical Device environment. Advanced knowledge and expertise in Computer System Validation, FDA, international requirements, and Part 11 requirements are required.

A Bachelor's degree in a relevant field, such as Biology, Chemistry, Computer Science, or Technology, is preferred. Laboratory experience as a chemist or microbiologist is also preferred.

Responsibilities:

  • Improve the effectiveness and efficiency of the existing CSV delivery model
  • Provide thought leadership for GMP Systems
  • Contribute to operational and process improvement initiatives
  • Apply CSV expertise to make a major contribution to a specific business unit or department
  • Interpret and execute company policies and procedures
  • Develop Validation testing strategy in accordance with Gilead's policy and procedures
  • Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites
  • 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, become proficient the EDMS (Electronic Data Management System), for document review, 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


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