• Interact with, Facility/Operations Managers, planners, and technicians for keeping the Preventive and Predictive Maintenance Programs accurate. • Facilitates root cause investigations for equipment failures.• Responsible for managing the Refrigerant Management Program.• Work with outside contractors to address operational differences and based upon findings submit project request to mitigate risk. • Responsible for submitting all small to medium projects and coordinating project hand over to the site minor works project managers. • Coordinated a project to identify all non-registered assets on site and worked with asset manager to have assets setup in CMMS system with appropriate maintenance plan.• Initiated a project to ensure all pressure vessels are registered with the state of Pennsylvania. Working on a project with my GSK counterpart to have pressure safety devices registered. • Works with Operations managers, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations

• Supervised the daily activities for manufacturing/ engineering department consisting of six employees. • Planed, directed and coordinated manufacturing processes/improvements.• Monitored preventative maintenance.• Analyzed and planed work force utilization, workflow, space requirements to maximize efficiency and design layout of equipment.• Performed feasibility studies/ROI calculations on projects to provide support for new capital improvement projects.• Conferred with management, engineering and other staff regarding manufacturing capabilities, production schedules and other considerations to facilitate and improve and production processes.• Assigned and reviewed IQ’s, OQ’s and PQ’s as required for validation.

· Worked with Quality Approver to author high quality GMP investigations within the Varicella Manufacturing Operations, while adhering to safety and compliance practices.· Performed investigations on equipment failures to determine causation: either human or mechanical. Implemented viable corrective actions, including, but not limited to new equipment or increased maintenance.· During a recurring failure investigation of end caps, I determined the causation to be a slight variation of grove width amongst different manufacturers, which had gone unnoticed for quite some time. When a cap failed, the entire batch was lost. I recommended and implemented revised specifications for the end caps. When the end caps not within the revised specifications were discarded or no longer purchased, the failure rate dramatically dropped.· Investigated major processing equipment failure such as process vessels, valves, heat exchangers, pumps, tubing, process filters, flow meters, temperature probes, sonicators and gaskets. Used Root Cause Failure Analysis and Failure Mode & Effects Analysis and appropriate specification (ASME, ASNI) to determine causation of failures and worked with internal and external experts in developing proper corrective actions.

· Managed a three-shift operation of 15 employees including 2 supervisors in a union environment to drive down the amount of non-conforming product and to increase productivity.· Maintained accuracy and ordering of departmental inventory of $6,000,000.· Implemented in-process improvements to increase productivity, reduce material losses and decrease downtime.· Coordinated with engineering department to update process for efficiency and to evaluate new equipment.· Managed production with the mill-manufacturing department to reduce downtime by ensuring department was set up to produce new product without interruption.· Revised SOPs and JSAs where necessary to reflect current process and procedures.· Trained 15 new and current employees on departmental safety and statistical process and created an action plan for potential hazards of new product, adjusting calculations when necessary.· Coordinated all departmental maintenance issues with the maintenance department and engineering to ensure equipment was working adequately and designed equipment to create efficiencies. · Managed all HR issues including counseling with union associates to ensure policies were met.

· Supervised 8 associates in daily purification duties and esured that personnel under supervision were properly trained in current Good Manufacturing Practices, procedures, documentation practices and regulatory matters· Optimized the process including balancing workload versus man-hours and insured availability of correct processing equipment and materials.· Worked with process development group to transfer technology from a lab scale operation to a pilot plant operation.· Approved all batch records and SOPs to ensure technical validity and quality for revision and final review. · Interviewed, hired and trained 4 associates to ensure department was adequately staffed and met department safety and regulatory standards. · Managed 8 associates including disciplinary action, motivation, training, interviewing, hiring, and problem resolution for subordinates· Coordinated production activities and requirements with three other departments to reduce down time and to make sure department was properly set up for optimum performance.· Coordinated process development with clients and the process development group to ensure that the rigid production schedule was met.

· Supervised daily activities for a production suite consisting of seven employees on one shift· Supported Manufacturing as Automation specialist troubleshooting Proconex DCS, Delta, and RMNT process control systems.· Developed and implemented SOPs for the start up of new processes and revised SOPs to reflect changes to the processes.· Facilitated communication between three production suites to minimize lost production time.· Provided recommendations for production schedule to production schedulers to reduce the amount of down time and to ensure adequate staffing for department.· Initiated and monitored process operations using a computerized distributed control system.· Performed in-process analyses from samples to ensure that all process parameters were within specification.· Managed purification using: chromatography columns, UV detectors and flow meters.· Conducted ultra-filtration and dia-filtration of biopharmaceutical proteins.· Supervised the relabeling of all process and equipment in two production suites to ensure that all equipment was properly labeled and there were no discrepancies between SOPs and process diagrams. · Member of safety committee and coordinated safety training.· Recommended, developed and implemented numerous process and safety improvements.· Reviewed and corrected all process instrumentation diagrams for the entire building.· Worked with senior level engineers to modify and improve manufacturing process.· Prepared reports for FDA pre-approval inspection.· Trained several employees in process operations to ensure that personnel were properly trained in cGMPs, procedures, good documentation practices and regulatory matters.· Coordinated preventative maintenance with maintenance department to reduce lost production time.

· Supervised the training 25 employees on four shifts on process operations and process chemical analysis.· Investigated all non-conforming batches and determined causation and followed up with appropriate corrective actions as required.· Lead associate on shift and on-call at all times for process recommendations and corrective actions.· Resolved conflicts between internal and external customers. · Developed and implement numerous SOPs. · Supervised field verification versus process and instrumentation diagrams.· Verified that all equipment was properly labeled and properly installed.· Assisted in the development of calibration curves in the determination of hydroxyl values for Near-IR Analysis.· Prepared statistical reports for internal and external review.· Project leader of the team to reduce production cycle time and increase productivity and quality.· Implemented Statistical Process Control in cooperation with plant and production manager.· Worked extensively with plant chemist to determine causes and solutions for batches that were out of specification.· Lead associate for addressing production safety concerns and worked with the appropriate corporate engineering department to rectify safety concerns.