Senior Manager, Computer Systems Validation
Current• Oversight of CSV projects on 4 company sites including 2 new facility start-ups.• Direct and coordinate validation activities of contractors, vendors and service providers.• Act as IT Quality Systems SME during audits.• Review and improve CSV procedures and business processes.• Serve as liaison with IT and Automation Engineering departments to achieve compliance. • Create and execute Data Integrity remediation plan using GAMP maturity model.• Implement and validate site-wide systems such as Chromeleon Enterprise CDS, Cytiva Unicorn, eMaint CMMS, Ignition SCADA and NetSuite labeling solution.• Configure and validate QC computerized systems including Thermo Fisher HPLCs, Mass Specs and PCRs, Agilent UV-Vis, Bioanalyzers and Fragment Analyzers, Bio-Rad Thermocyclers and qPCRs, Charles River Endotoxin Testing Systems.• Configure and validate Manufacturing computerized systems including Custom TFF and Chromatography Skids, Cytiva AKTAs and Wave Bioreactors, Sartorius Hiperseps, AST Vial Filler and Sealer, Single Use Support Aseptic Filling System.• Validate Facility computerized systems including Building and Environmental Management Systems (BMS and EMS), RODI and WFI Skids, Solvent Delivery System.
