Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility.- Establish, develop, and maintain Electronic Record Systems- Drafting, routing, and revising manufacturing batch records, procedures, supporting records- Manufacturing process support during on-going shop floor execution, when required- Support new equipment enrollment efforts from purchasing to qualification activities- First line of defense for manufacturing events. The candidate will assess the event and provide immediate corrective actions- Lead implementations for corrective and preventive actions- Point of contact for laboratory equipment supporting manufacturing operations, troubleshooting, vendor calls, equipment repair coordination, operational changes, and system qualifications- Support Safety initiatives, compliance, and quality requirements

Under the supervision of the Upstream/Downstream Process Manager or Supervisor, I was responsible for the execution of activities for biopharmaceutical production. Responsibilities involved day-to-day ongoing biopharmaceutical production, documentation and process efficiency improvements.• Execution of production processes to meet manufacturing and business requirements• Involved in process scale-up, process optimization and process validation activities• Adhering to and development of documentation, including standard operating procedures and batch records• Coordinates inventory of consumables for production• Supports the generation and resolution of process deviations• Inspect and maintain the production equipment and control systems• Collaborates with process support and development groups to assure smooth process transition in manufacturing• Support department management in developing and providing training for the process floor• Inputs, reviews, and trends batch production data to support campaign summary report completion• Ability to work flexible schedules during process start-up and ongoing operations• Maintain company health, safety, and environmental standards