Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Quality Assurance Validation Consultant (Contractor)

  • Nov 2017 - Present

  County Limerick, Ireland Supported CIP/SIP validation for upstream/down stream manufacturing equipment. Equipment validated included Bioreactors, Media Preparation Vessels, Centrifuges, Filters, Capture Load Tanks, Chromatography Skids. Generated, executed and reviewed master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Analyzed testing (SIP/CIP) results to determine… Show more Supported CIP/SIP validation for upstream/down stream manufacturing equipment. Equipment validated included Bioreactors, Media Preparation Vessels, Centrifuges, Filters, Capture Load Tanks, Chromatography Skids. Generated, executed and reviewed master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Analyzed testing (SIP/CIP) results to determine the acceptability of results against pre-determined criteria. Reviewed and Approved Executed Qualification and Validation Protocols. Investigated problems to determine solutions or recommendations for changes and/or improvements. Generated and reviewed deviation notifications, deviation investigations, and corrective actions. Reviewed and edited change controls, SOPs, reports and other documentation. Collaborated with functional departments to resolve issues. Proficient in the critical review and approval of KAYE validator report and study runs. Developed a good knowledge of Steam in Place (SIP) thermal mapping, TC and BI placement. Proficient in the execution of Baseline Studies, TOC rinse and Swab sampling. Developed a solid understanding of Bio manufacturing, Clean in Place, and Steam Sanitization methods. Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Scientist (Contractor)

  • Mar 2016 - Mar 2017

  Medical Devices Test Method Center of Excellence (Startup Laboratory) Supported the Qualification of Analytical Instruments (Computerized Systems, COTS, and stand-alone systems) as per regulatory guidelines. Systems Validated included UPLC’s, HPLC’s, FTIR, UV, Balances, pH Meters, Ovens, Milli Q Water System, Hydrogen Gas Generator. Developed, Validated and Transferred Analytical Chemistry Methods for a number of Johnson and Johnson Medical Devices and Pharmaceutical Finished Products (HPLC and UPLC). Developed methods in line with ICH guidelines… Show more Supported the Qualification of Analytical Instruments (Computerized Systems, COTS, and stand-alone systems) as per regulatory guidelines. Systems Validated included UPLC’s, HPLC’s, FTIR, UV, Balances, pH Meters, Ovens, Milli Q Water System, Hydrogen Gas Generator. Developed, Validated and Transferred Analytical Chemistry Methods for a number of Johnson and Johnson Medical Devices and Pharmaceutical Finished Products (HPLC and UPLC). Developed methods in line with ICH guidelines via a Quality by Design (QbD), with Design of Experiments (DoE) approach using Empower and Statistical Analysis Software (Minitab) to ensure the Accuracy, Repeatability and Robustness of the Analytical Methods. Authored/reviewed Development, Validation and Transfer Protocols. Authored/reviewed SOP’s and Test Methods pertaining to the Validated Methods. Reviewed executed Development, Validation and Transfer Protocols. Reviewed Raw data generated during development, validation and transfer to ensure adherence to predefined specifications. Authored/reviewed Summary Reports. Used Scientific Problem Solving Tools (Six Sigma DMAIC) and Statistical Analysis Tools (Minitab, Excel) to carry out GAP Assessment’s and Investigations, and to insure continuous Improvements. Reviewed Development, Validation and Transfer Protocols and Reports. Reviewed Raw data generated during development, validation and transfer to ensure adherence to predefined specifications. Carried out Laboratory Audits to ensure the maintenance of GLP standards. Reviewed Instrument Logbooks, Laboratory Notebooks and computerized systems (stored data) for accuracy, completeness and data integrity. Liaised with clients from various Johnson and Johnson sites to present data and discuss issues such as project feasibility, strategies, key mile stones and technical issues. Ensured that all research and validation was carried out according to GMP and ICH guidelines and that all data generated was of the highest integrity. Show less



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Chemist

  • Mar 2007 - Mar 2016

  County Waterford, Ireland Validated Firmware, Standalone systems and computerized systems in accordance with current best practice. Carried out Risk Assessment’s and High Level Risk Assessment on new equipment. Reviewed Vendor IQ, OQ and PQ paper work, supported vendors during IQ, OQ, PQ execution, and reviewed results generated during testing. Wrote and executed IOQ’s, updated/generated SOP’s and Logbooks for Qualified Instruments, provided practical training or online training where appropriate… Show more Validated Firmware, Standalone systems and computerized systems in accordance with current best practice. Carried out Risk Assessment’s and High Level Risk Assessment on new equipment. Reviewed Vendor IQ, OQ and PQ paper work, supported vendors during IQ, OQ, PQ execution, and reviewed results generated during testing. Wrote and executed IOQ’s, updated/generated SOP’s and Logbooks for Qualified Instruments, provided practical training or online training where appropriate. Systems validated included: Melting Point Apparatus, Centrifuges, pH Meters, FTIR, Nitrogen Gas Generator, CTU's, Glass Washers, Cary UV. Carried Laboratory Investigations and Risk Assessment’s e.g. performed worse-case scenario product removal investigation on Laboratory Glassware for the Qualification of the Laboratory Glass Washers. Collaborated with Devices Engineering during the Clinical Trial manufacturing of a new inhalation’s device, with the objective of writing appropriate Quality Control Components Testing Methods. Wrote Raw Material and Finished Product Quality Testing Methods for the Active Ingredients and Excipient’s within the device. Planned and Performed the Routine Analysis of Components, A.P.I's, Excipients, Intermediates, Finished Products and Stability Samples. Testing Included: Assays, Dissolution and Content Uniformity - HPLC and UV. Identification - UV, FTIR, NIR and Wet Chemistry Tests (e.g. TLC, Heavy Metals, Lead, ROI). Particle Size by Malvern Particle Size Analyzer, Sieve Analysis, Alpine Air Jet (API’s), and Next Generation Impactor Testing (Dry Powder Inhaler) Moisture Content by Karl Fischer. Purified Water Testing - TOC, pH and Conductivity. Updated and Generated Controlled documents using technical writing skills. Reviewed analytical test data. Prepared for Laboratory Audits. Trained new employees in routine analytical methods, and equipment use/calibration. Investigated and progressed Customer Complaints and material returns. Show less