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Senior CSV / Lab Instrument Validation Consultant

AdeptSource

  • Foster City, California
  • 30+ days ago

    Highlights

    CSV / Lab Instrument Validation Specialist Type of role: Contract Duration: 12-36+ months Hourly pay rate: DOE (C2C, W2, or 1099 permissible) Location: South San Francisco Bay Area (Remote during COVID) Our customer is seeking a Senior CSV / Lab Instrument Validation Engineer who is well versed in laboratory Instrument processes within a Pharmaceutical environment. Responsible for developing and executing on validation plans according to approved procedures, collation of test results, and organizes data packages and maintains all documentation pertaining to validation.

    Numbers & Facts

    LocationFoster City, California
    IndustryComputer/IT Services
    Company Size50 to 99 employees
    Year Founded1999
    Websitehttp://www.adeptsource.com

    Description

    Sr. CSV / Lab Instrument Validation SpecialistType of role: ContractDuration: 12-36+ monthsHourly pay rate: DOE (C2C, W2, or 1099 permissible)Location: South San Francisco Bay Area (Remote during COVID) Our customer is seeking a Senior CSV / Lab Instrument Validation Engineer who is well versed in laboratory Instrument processes within a Pharmaceutical environment. Must have hands experience on Lab Instrument Qualification.  You will be primarily responsible for planning, leading, and executing validation efforts for standalone Lab Instrument Software systems.Must have strong experience in the following:
    • Responsible for performing validation of Laboratory Instrumentation by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
    • Responsible for the mapping and bringing consistency to the  instrument lifecycle globally,  from supporting purchase to instrument validation to decommissioning documentation.
    • Plan, lead, and execute the standardizing of validation efforts for standalone Lab Instrument Software systems.
    • Responsible for developing and executing on validation plans according to approved procedures, collation of test results, and organizes data packages and maintains all documentation pertaining to validation.
    • Ability to compile and analyze validation data, prepare reports and makes recommendations for changes and/or improvements.
    • Well versed in Laboratory Instrument process, ability to provide guidance to management on what improvements need to be made. (Essential for this role)
    • May also investigate and trouble-shoot problems which occur, and determine solutions.
    • Support change management and manage existing lab systems.
    • Participates on cross-functional project teams with the support of Development, Quality, and other groups
    • Familiar with FDA guidelines for Instrument and Software validation.
    • Experience must come from a pharmaceutical, biotech industry with direct knowledge of FDA regulations including 21CFR Part 11.
    • Self-motivated, good communication, technical writing, presentation skills, detail oriented, analytical, and a team player.  

    About Company

    With offices throughout northern and southern California and administrative offices near Austin, Texas, AdeptSource provides industry specific IT professionals on a temporary or full-time basis to biotech customers nationwide. We also provide Professional Services and Managed Services on a project basis. Our extensive background, technical expertise, and excellent reputation demonstrate our ability to consistently deliver results to our partners.  AdeptSource is your partner in finding and evaluating top talent to help you achieve your IT staffing goals. In a seemingly endless pool of IT professionals, we provide quality candidates on-time and with less expense. Spend less time vetting potential candidates and more time focused on achieving your IT goals.

     At AdeptSource, we provide biotech customers with talented IT professionals of all types who possess multi-level experience and specialized skills in an exceptionally wide variety of industries, platforms, languages, and development tools. Why use AdeptSource?....

    • The deep technical knowledge and vast experience of our recruiting team delivers significant value to clients, making AdeptSource your ideal business solutions partner.
    • Our organization is divided into specialized solutions groups. Our focus on delivering solutions for industry specific needs guarantees the right expertise of every AdeptSource staff member and consultant on every project.
    • We are proud to provide consulting support and a true busines spartnership to our client, combined with high standards and business ethics, without the traditional sales pressure.
    • We have a heart for needy children, which is why we are committed to doing something about it. For every candidate we help our clients hire, AdeptSource sponsors a child through our corporate partnership with Arms of Love International.

     

     

     

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