1+ months

/Drug Substance Technician

Pfizer
Plant City, FL 33563
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cGMP

Participate in the execution of pharmaceutical manufacturing processes. Execute manufacturing and qualification/validation activity, including product operations, suite clearance and changeover, equipment processing, solution formulation, manufacturing batch record review and special sample coordination. Provide support in troubleshooting activities, technology transfer and start-up activities. Support superviser to execute investigations, analyze process data and identify and implement process improvements. Provide support of process of experimental design with regard to system mixing, mass transfer, and other pertinent aspects of bioprocess system control. Author and present comprehensive technical presentations and procedures. Thorough understanding of cGMP requirements and safety practices and provide audit support to several internal and external audits.



+ CROCTAProvide local execution support during CTA lot execution at CROs.

+ SOPPerform standard operating procedures of DS startup/scaleup/clinical lots production in new facility.

+ SOPAuthor documentation such as batch records, procedures, and validation reports as directed by supervisor.

+ Provide real-time RFT support of critical operations.

+ Work with supervisor to communicate and resolve operational variances.

+ /Process monitoring including real time review of process parameters and process data/trend analysis.

+ Communicate process performance across shifts and departments.

+ Support supervisor to Implement process enhancements, measure and respond to equipment capability and implement new technologies.

+ Execute operation following QEHS regulations.

+ Participate investigations, and change controls to ensure changes are value added and processes and equipment are robust.

+ Participate a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs.

+ Provide Audit support

+ Execute other items assigned by supervisor.

+



Attend shift work according to manufacturing requirement.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Manufacturing
Posted: 2020-10-13 Expires: 2020-12-13
Sponsored by:
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/Drug Substance Technician

Pfizer
Plant City, FL 33563

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