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LabWare LIMS Validation SpecialistFoster 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.