Over 14 years experience in the pharmaceutical and biotech industries, with experience in engineering, commissioning, validation, manufacturing, and quality assurance in the Bulk Pharmaceutical Chemical, Solid Dosage and Biologics industries.
Experience includes projects management for the validation of equipment and utilities, cleaning validation, computer validation and process validation.
Worked with over twenty-five different clients at facilities throughout Europe and the United States : Hoechst Marion Roussel and Pfizer's DM 300 million worlds largest insulin plant, Novartis-subsidiaries Biochemie and Genetic Therapy, Boehringer Ingelheim-Austria and Germany, Baxter, Bayer, Chiron and Hoffmann-La Roche.
Specializing in regulatory compliance for agencies like the FDA and EU/EMEA.
Computerized systems with 21 CFR Part 11 compliance and validation includes specialized training, compliance assessments and validation of SCADA Systems like Wonderware - InTouch and FIX-DMAX, Process Automation and Building Automation Systems like Honeywell and Siemens, Allen Bradley and PLC Panel Builder, LIMS, MES, MRP and SAP.