Media Value Stream Lead Resume Example

• Gowned aseptically into grade C and D to work in a clean room environment.
• Executed dry runs of media process to test electronic batch record.
• Oversee media module and provide support to all media activities.
• Train new associates in operating and verifying bioreactor days and media process.
• Aseptic processing in ISO 5 biosafety cabinets.
• Universal precautions for handling human derived materials in BSL-2 containment areas.
• Provide support to peers on operations as MES Super User.
• Used production related IT systems such as SAP, MES and LIMS on daily basis.
• Performed in process operations such as: bioreactor sampling, static sampling and in process environmental monitoring.
• Worked with automated cell processing equipment such as the wave bioreactor.
• Documented all steps in the assigned Batch record in line with GMP requirements.
• Cell expansion using incubators and single use bioreactors.
• Assisted on deviation investigations and inspections.
• Maintained an “audit ready” module

• Handled formulation and processing of Antibody Reagents and Diluents in accordance with written procedures and specifications.
• SAP Power User: Performed (ERP) inventory transactions, adjust quantities work orders, cycle count, MUV analysis and scrap authorizations. Ensure availability of materials/components for efficient operation. Accurate data entry skills in ERP system.
• Worked with Human blood in process of formulation.
• Performed in process review of batch records/witnesses formulation of products. Document work done and perform all support functions on compliance with departmental, company, and government procedures and regulations.
• Performed in process testing as required by processes and procedures utilizing equipment/instrumentation such as: pH meter, specific conductance, viscometer, spectrophotometer osmometer, calibrated pipettes, centrifuges, incubator and water bath.
• Wear the appropriate PPE when working in lab environment and other hazardous working environments.
• Participated in investigations regarding new products and process improvements, as required. Responsible for using equipments for the assembly and processing tasks to produce products according to established specifications.

•Troubleshooting of routine manufacturing equipment and processes

•Maintains and performs basic repair on labeling machines and equipment •Inspecting various product put-ups to ensure product is free of defects

•Perform in-process review of batch records and documents work done •Demonstrate complete understanding for all processes and performs all assigned manufacturing tasks

•Responsible for labeling of all products

•Good knowledge of math and metric system

•Check product on assembly line to confirm that they are properly assembled •Complies records and reports on quality inspection results