Process Technician

JASON P CAUSING

908-***-**** (Cell)

** ******* **.

Edison, NJ 08820

********@*****.***

Experience

Validation Technologies, Inc, San Diego, CA Dec. 2012 to June 2013

Validation Specialist

Generation of IQ/OQ/PQ protocol and Final Report for different process and laboratory equipment and utility system. Assisted in factory acceptance test, validated different process equipment, skids and stainless steel tanks. Assisted in derouging, passivating purified water and water for injection systems with the help of an outside consultant. Preparation of solution such as elution and regeneration buffers. Mammalian cell culture scale up from 10L to 20000L bioreactor. Expedited training of new associates for use and operation of process equipment. Perform CIP and SIP of bioreactors, filtration skids, chromatography skids and process vessels using DCS and HMI Control system. Perform process operation by following Batch Record and Standard Operating Procedures (SOP) in accordance with GMP. Review of batch records

Bayer Healthcare, Berkeley, CA Feb. 2012 to Nov. 2012

Process Technician

Task include line check, process monitoring, trending of PCO2, Dissolve O2, temperature, flowrate, pressure and pH for 6 fermenters. Set-up and operate protein collection using cell separation skid to ultrafiltration skid to product tank. Daily sampling of fermenters. Operate and calibrate blood gas analyzer, cell counter, YSI, TOS, pH and conductivity meter. Assemble

tubing manifolds and autoclave fermenters, settlers, and portable heat exchanger. CIP ultrafiltration skid and process tanks. Clean, sanitize cell separation skid. Generate, initiate and complete process electronic batch record. Prepare buffer solution used for processing. Connect buffers to fermentor as needed. Initiate and execute product and buffer transfer using DCS and HMI. Transfer product from hold tank to receiving tank using MES system.

Genentech, South San Francisco, CA Oct. 2008 to Sept. 2010

Packaging/Final Product Inspector

Inspect different liquid vials and lyophilized products strictly adhering to all SOPs, GMPs, and safety guidelines during the manufacturing process. Perform final product receipt, sampling,

inspection, reconciliation, document rejects in ticket and delivery of inspected vials to material

handling. Accurately complete detail of process-related documents. Package all products with

focus on quality and efficiency.

Skills

Microsoft Office 2013, Outlook, HMI and DCS

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