Operation Technician Resume

SUMMARY

PAS X, Delta V, LIMS, BACH, Sampling, SAP (cycle counts), SOPs, and Electronic, Paper Batch Records, and pipetting experience production
Experience in attaining clean room gowning certification and work with hazardous materials
Hyper - Care support for new EM project (GLIMS)
Ability to be trained in multiple processing areas, and provide support when needed
Leads team meeting, compliance and safety walkthroughs, Red line SOPs
Eighteen years of experience in the manufacturing industry

PROFESSIONAL EXPERIENCE

Confidential

Operation Technician

Responsibilities:

Performs the manufacture of clinical supplies working closely with customers and R&D scientists in the development and scale up of new products and processes.
Assists in the scale up of pilot development trails to production processes and is primarily responsible for the manufacture of Pulmonary & Nasal Products.
Maintain accurate inventory and tracking records of supplies and equipment.
Fill product in aseptic processing area in compliance with SOPs batch record and CGMPs
Prepare and verify BOM (Bill of Materials) and set up all the equipment for production and packaging.
Finish all end of batch documentation as well as reconciliations of the wasted/return material back to the warehouse.
Perform all steps and processes necessary for preparation and finishing of experimental and CGMP product batches.
Review experimental pilot trails working closely with scientists and equipment.

Confidential

Bio-Process Technician

Responsibilities:

Perform all duties and responsibilities in compliance with standard operating procedures.
Follow aseptic procedures, document actions in real-time manner, set-up, clean, operate robotic equipment, assemble, prepare materials and supplies for production, maintain a safe and clean work environment by following current Good Manufacturing Practice, Participate in training opportunities, provide general support to manufacturing team, Phase 4 (Cell Plant, Refeed, Innoculate, Environmental Monitoring ).