Elvyn Robles

Experience

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  Abbott Laboratories

  Jan 1999 - Jan 2005

  Chemical Operator

  Antibiotic production by Continuous Sterilization Systems, Decanters, Seeds and Fermentors Tanks. Perform process control by utilizing computer programs such as: Provox, G2, PI Graphics and BPCS. Process sampling for sterile diagnostic and growth conditions (Bio Assay, Oil Assay). Performed equipment maintenance (Chemical Wash, Cleaning in Place Process and Work Orders coordination). Perform reactions, crystallization, milling, centrifuges and blenders in the Finishing chemical process. Process sampling for QA compliance, and equipment maintenance (Chemical Wash, Cleaning in place process). Show less

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  Abbott,Laboratories

  Jan 2005 - Jul 2007

  Fermentation Production Supervisor

  Supervise, coordinate and organize the work schedule of the operating personnel in the Fermentation and Extraction areas. Manage and control operating expenses within approved budget. Assure that all manufacturing documentation is in compliance with cGMP, BPCS & GPO policies and guidelines. Audit manufacturing Batch Records, Logbooks and equipment cleaning data. Troubleshoot the operations and maintain product quality and a safe operational condition. Assure that operating personnel is trained in all the applicable and required procedures and Company policies. Assure that deviations are documented. Develop and implement corrective actions. Evaluate operating personnel performance and develop individual developmental plans when requires people behavior improvements. Maintain a healthy working environment in the area of responsibility. Provide and assure that the operating personnel are equipped with the required safety tools, equipment and uniforms to avoid personnel injuries or hazardous exposures. Assist and support Abbott’s EHS Program. Establish the proper planning and schedule of the equipment maintenance and repairs assuring that throughput were not affected by downtime. Participate and collaborate in the Foreign Growth Prevention Team, and lead the plant EHS Safety Team for the Fermentation, Extraction, and Chemical departments. Show less

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  Abbott Biotechnology

  Jul 2007 - Apr 2012

  Biologics Senior Supervisor

  Assigned to supervise and serve as a facilitator of the manufacturing personnel of the Buffer and Media Solution Preparation, Glass Wash, Autoclave and Alarms areas. Provide and assure that the operating personnel are equipped with the required safety tools, equipment and uniforms to avoid injuries or hazardous exposures. Assist and support EHS Program. Manage and control operating expenses within approved budget. Assure that all manufacturing documentation is in compliance with cGMP and company policies and guidelines. Audit manufacturing Batch Records, Logbooks and equipment cleaning data. Troubleshoot the operations and maintain product quality and a safe operational condition. Assure that operating personnel is trained in all the applicable and required procedures and Company policies. Assure that deviations are documented. Develop and implement corrective actions. Establish the proper planning and schedule of the assigned equipment maintenance and repairs assuring that throughput were not affected by downtime. Evaluate operating personnel performance and develop individual developmental plans when requires people behavior improvements. Maintain a healthy working environment in the area of responsibility. Show less

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  Abbott Biotechnology LTD

  Apr 2012 - now

  Biologics Production Superintendent

  Biotechnology manufacturing superintendent assigned to supervise the operating personnel in the Buffer and Media Solution Preparation, Glass Wash, Autoclave and Alarms areas. Provide and assure that the operating personnel are equipped with the required safety tools, equipment and uniforms to avoid injuries or hazardous exposures. Assist and support EHS Program. Manage and control operating expenses within approved budget. Assure that all manufacturing documentation is in compliance with cGMP and company policies and guidelines. Audit manufacturing Batch Records, Logbooks and equipment cleaning data. Troubleshoot the operations and maintain product quality and a safe operational condition. Assure that operating personnel is trained in all the applicable and required procedures and Company policies. Assure that deviations are documented. Develop and implement corrective actions. Establish the proper planning and schedule of the assigned equipment maintenance and repairs assuring that throughput were not affected by downtime. Evaluate operating personnel performance and develop individual developmental plans when requires people behavior improvements. Maintain a healthy working environment in the area of responsibility. Show less

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  AbbVie

  Sept 2013 - now

  Biologics Production Superintendent

  Supervision of biologic manufacturing operations. Assigned to monoclonal antibody purification operations; ion exchange and hydrophobic chromatography, filtration, viral inactivation, tangential filtration, diafiltration and aseptic product filling. Responsible to plan and control the biotech downstream manufacturing operation schedule to meet Plant throughput while maintaining cost and manpower utilization efficiently. Accountable of the implementation and start up of capital projects for new equipment's, tech transfer, facilities improvements, and systems process control. Assure that deviations from approved procedures are documented and investigated. Conduct production deviation investigations, writing, develop and implement corrective actions to prevent deviation recurrence. Anticipate and correct situations that affect the operating and environmental conditions for the people and the equipment. Evaluate columns chromatograms and process key performance indicators for scientific further analysis. Assure that manufacturing facilities and equipment are maintained in appropriate conditions by implementing effective manufacturing room’s bioburden and particles prevention and control. Contributed in the startup of a new biotechnology product as third party manufacturing by creating the downstream manufacturing directions and training the personnel for the engineering and process validation runs. Review and release paperless (MES) batches records exceptions under the cGMP’s requirements. Developed several MES recipes for manufacturing execution and improved several others as part of the quality Right the First Time initiative. Show less