Lockport, Illinois, United States
Plan, execute and document all activities related to validation and re-validation of equipment, processes and software used in the manufacture of In-Vitro diagnostic microbiological products to assure compliance with FDA GMP, USP, ISO internal and external requirements and regulations. • Development, validation and continued support of equipment and processes used for steam sterilization of product and materials used to produce products. • Validation (IQ/OQ/PQ) of equipment, processes and software used for manufacture and testing of products including autoclaves, bulk sterilizers, freezers, refrigeration systems, material storage areas, incubators, lab test instrumentation, water purification systems,aseptic and non-aseptic fill lines. • Led projects that drastically improved processes, optimization and quality improvement for new and existing processes and equipment. • Managed equipment and instrumentation evaluation, documentation and calibration program for all production process and laboratory / test equipment. • Managed other support activities for scheduled maintenance and certification of equipment and instrumentation (i.e. laminar flow hoods, biological safety cabinets, clean room and fill line HEPAs, lab equipment cleanings, etc.). • Managed environmental monitoring system that utilizes RF based sensors to continually monitor temperatures, humidity and pressures for manufacturing process equipment, test equipment and controlled environments throughout facility. • Provided daily technical support to manufacturing for equipment and manufacturing process (product compounding, sterilization, aseptic and non-aseptic fill lines, packaging and labeling equipment, QC test instrumentation and equipment, data management systems, etc.). • Provided hardware and software support for product labeling systems. • Performed investigations and support for NCMR and CAPA activities related to equipment and environmental deviations.
Managed activities relating to quality control and GMP compliance of blown film, printing, laminations and converting operations. • Provided direct support to production departments relating to development and maintenance of quality systems, GMPs and regulatory compliance. • Installed and provided ongoing support and training for real time electronic quality database and SPC systems used in production and quality control. • Performed internal and external audits to assure compliance with regulatory, ISO, internal and external requirements. • Worked with other QC, production, engineering and management personnel to employ 6-Sigma and general statistical methodologies aimed at process improvement and problem solving. • Served as member of internal Corporate Quality Council and external member of organizations such as PDA, ASTM and Flexible Packaging Association to develop and promote industry standards.