Engineering, Procurement, and Commissioning

• Managed the selection, procurement, installation, commissioning, and validation of two 100 cm diameter, hydraulically-actuated chromatography columns for use in the manufacture of biopharmaceutical products
• Prepared the technical specifications for purchase of two 100 cm diameter, hydraulically actuated chromatography columns, hydraulic power unit (HPU), and packing station
• Evaluated bids, prepared procurement documents, monitored manufacturing process, reviewed and approved submittals, and prepared field acceptance test protocol
• Prepared the Requirements/Design document that provided the basis for validation of the mechanical and automated components of the columns and HPU.
• Supervised the installation and commissioning, and executed the site acceptance testing and validation of the columns and HPU
• Prepared turnover package, maintenance plans, standard operating procedures, and developed spare parts inventory requirements