Computer System Validation (CSV) Specialist
Irvine, CA Posted: 1/24/2019
Client is performing a technology refresh to replace non-compliant older equipment and software with the latest systems allowing for state-of-the-art control and audit trail (i.e. a new LIMS, new software for spectrophotometers, new software for secure data collection from Metler Toledo instruments: balances, titrators (Karl Fisher) and pH meters; FTIR (Agilen Technologies MicroLab and Cary WinUV, Charles River Cortex (for Endosafe instruments) as well as connection of instruments to network servers and/or the new LIMS.
Client is seeking improved CSV/IT support to ensure technical IT solutions (such as connecting instruments to network server for data storage, configuring compliant access control, etc.) and validation of the new technologies and software arising from Control #2 above are implemented in a timely and compliant manner.
- The validation consultant will perform CSV remediation for laboratory instrument, manufacturing automation, and IT Infrastructure
- The CSV consultant will perform laboratory instrument / software validation
- The computer system validation activities include validation and support of systems such as Waters and Agilent HPLC systems, Waters Empower CDS, FTIR Agilent (MicroLab) ChemStation software, UV-VIS, AA, TOC, plate reader.
- The CSV consultant would create and develop SOPs, Validation templates.
- Prefer candidates with experience in the following systems: LabX, LabWare LIMS, Agilent MicroLab FTIR and Cary WinUV, Charles River Cortex (for Endosafe instruments)
Candidates should have a Bachelor’s Degree with 8 to 10 years of experience in Computer Systems Validation in a cGMP environment.
Job Type: Contract
- Computer Systems Validation: 8 years (Required)
- LIMS Validation: 8 years (Required)
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