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LabWare LIMS Validation Specialist

Foster City, CA · Biotech/Pharmaceutical
Title: LabWare LIMS Validation Specialist
Location: San Mateo, CA
Type of position: Contract
Duration: 12-24+ Months
Provide validation activities for projects involving Labware LIMS.
  • Minimum of 6 years of CSV experience in a Pharma/Biotech environment.
  • Must be versed in LabWare LIMS and have previous experience validating LabWare.
  • Prior experience validating / writing test scripts based on software configuration for LabWare LIMS is a must.
  • Must have very strong communication skills.
  • Experience in FDA regulated environment with good understanding compliance issues as well as cGxP (cGMP, cGDP, cGAMP, cGLP) standards, Risk-based validation and 21 CFR Part 11.
  • Conduct computer system validation work, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables.
  • Develop validation strategy documents, update / write user requirements, Functional and Design Specifications SOPs, IQ/OQ/PQ, perform test execution / lead execution activity and create validation summary reports.
  • Strong verbal and written communication skills are essential.
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