Kenneth Maxwell Email & Phone Number

Farmersville, Tx, Us

Schindellegi, Schwyz, Ch

Manage (equipment, processes, products, facility), Validations, Change Control, CAPA, Audit (Internal, External, Supplier), Process Improvement and Technical Reports.Collaborate with the definition and support of AQL's, sampling plans, statistical methods, statistical analysis, training of implemented statistical methods, and statistical tools.Supervise QSHE (Quality, Safety, Training, Health, Environmental, and Security) team.Project management leader in directing Facility improvements and projects.Support various performance and process improvement for equipment, personnel, and facility.Generate and revise protocols, SOP's, drawings, equipment specifications, Engineering Test Reports and technical reports.Implement and maintain the site Change Control (Management) Procedure for all product and process.Identify improvement activities and collaborate with area owners to implement.Perform Corrective and Preventative Actions (CAPA), root cause analysis.Knowledge of usage, repair, storage and calibration of monitoring devices and other instruments.Assist in the definition and support of appropriate AQL's, sampling plans, statistical methods, statistical analysis, training of implemented statistical methods, and statistical tools.Support Continuing Improvement in setup of equipment, validations of equipment, implementation and execution of protocols, documentation for a variety of equipment and processes.Training of personnel in the operation of equipment, processes, and procedures for daily use.Experience in temperature mapping of facilities, coolers, and freezers.Experience with HVAC qualification for temperature, relative humidity, and pressure.Facility validation, maintenance, and project managementExperience with CSV (Computer / Software Validations).

• Support Validation protocols and validation performance qualification and validation summary reports.• Generates and revises validation protocols, SOP’s, drawings, equipment specifications, Engineering Test Reports and technical reports.• Understand Corrective and preventative actions, root cause analysis, troubleshooting, knowledge of usage, repair, storage, and calibration of monitoring devices and other instruments used by Alcon.• Assists in the definition and support of appropriate AQL’s, sampling plans, statistical methods, statistical analysis, training of implemented statistical methods, and statistical tools.• Support Engineering in setup, implementation and execution of Installation / Operational Qualification protocols, PVS, and PQ’s for a variety of steam sterilizers and dry heat ovens.• Validation of Pharmaceutical equipment with experience in writing, executing, and support of protocols from start to finish using cGMP and FDA guidelines.• Experience in the execution both steam and water cascade sterilizers requalification’s, steam quality testing, and sterilizer validations for both normalization processes and terminal sterilization of products.• Experience in the execution of instrumentation validation protocols, environmental monitoring of aseptic conditions, processes, and rooms, validation of the fill capability of various pharmaceutical products, requalification of various instrumentations and procedures, and temperature mapping of warehouses, coolers, and manufacturing locations

Bad Homburg, Frankfurt, De

• • Support Validation protocols and validation performance qualification and validation summary reports.• Generates and revises validation protocols, SOP’s, drawings, equipment specifications, Engineering Test Reports and technical reports.• Understand Corrective and preventative actions, root cause analysis, troubleshooting, knowledge of usage, repair, storage, and calibration of monitoring devices and other instruments used by Fresenius Medical Care, and fundamental knowledge of PLC software.• Assists in the definition and support of appropriate AQL’s, sampling plans, statistical methods, statistical analysis, training of implemented statistical methods, and statistical tools.• Support Engineering in setup, implementation and execution of Installation / Operational Qualification protocols, PVS, and PQ’s for a variety of steam sterilizers and dry heat ovens.• Validation of Pharmaceutical equipment with experience in writing, executing, and support of protocols from start to finish using cGMP and FDA guidelines.• Experience in the execution both steam and water cascade sterilizers requalification’s, steam quality testing, and sterilizer validations for both normalization processes and terminal sterilization of products.• Experience in the execution of instrumentation validation protocols, environmental monitoring of aseptic conditions, processes, and rooms, validation of the fill capability of various pharmaceutical products, requalification of various instrumentations and procedures, and temperature mapping of warehouses, coolers, and manufacturing locations.

Pomona, Ca, Us

• Validation of Pharmaceutical equipment with experience in writing, executing, and support of protocols from start to finish using cGMP and FDA guidelines.• Experience in the execution both steam and water cascade sterilizers requalification’s, steam quality testing, and sterilizer validations for both normalization processes and terminal sterilization of products.• Experience in the execution of instrumentation validation protocols, environmental monitoring of aseptic conditions, processes, and rooms, validation of the fill capability of various pharmaceutical products, re-qualification of various instrumentation and procedures, and temperature mapping of warehouses, coolers, and manufacturing locations.

Dublin, Oh, Us

• Management, Supervising, Training, Education, and Monitoring of other technicians and chemist in the manufacturing and distribution of radio-pharmaceuticals for the express purpose of PET scans in hospitals and clinics. Responsible for site upkeep, technician training, and quality systems while manufacturing under cGMP guidelines.• Trained in almost all production and quality control of FDG, NaF, 13NH3, and several IND nuclear pharmaceuticals• Responsible for the validation, upkeep, and repair of all equipment used in the Radiopharmaceutical Manufacturing site. Validation of Chemical Synthesis Unit for FDG Manufacturing, Gas Chromatography, High Pressure Liquid Chromatography, Low Pressure Liquid Chromatography, Ion Chromatography, Dose Calibrator for radio-active assay for radio-nucleotides, Radionuclide Purity and Identity, Clean room validation, and Laminar Airflow workbench.• Clean Room Setup & Maintenance required in both FAB and Wafer chip production laboratories to ensure quality sample introduction and diagnoses including the repair of faulty instrumentation.

Dublin, Oh, Us

• Management, Supervising, Training, Education, and Monitoring of other technicians and chemist in the manufacturing and distribution of radio-pharmaceuticals for the express purpose of PET scans in hospitals and clinics. Responsible for site upkeep, technician training, and quality systems while manufacturing under cGMP guidelines.• Trained in almost all production and quality control of FDG, NaF, 13NH3, and several IND nuclear pharmaceuticals• Responsible for the validation, upkeep, and repair of all equipment used in the Radiopharmaceutical Manufacturing site. Validation of Chemical Synthesis Unit for FDG Manufacturing, Gas Chromatography, High Pressure Liquid Chromatography, Low Pressure Liquid Chromatography, Ion Chromatography, Dose Calibrator for radio-active assay for radio-nucleotides, Radionuclide Purity and Identity, Clean room validation, and Laminar Airflow workbench.• Clean Room Setup & Maintenance required in both FAB and Wafer chip production laboratories to ensure quality sample introduction and diagnoses including the repair of faulty instrumentation.