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Drug Product Operation/Process Technician


Hangzhou Plant
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Job Details

Provide local execution support during CTA lot execution at CROs/CMOs.

Execution of DP startup/scaleup/clinical lots production in new facility.

Act as team leader of an operation team of processs technicians.

Author and review documentation such as batch records, procedures, and validation reports.

Support DP supervisor to manage the team through the training, operations, performance etc.

Proactive and Right First Time execute of critical operations.

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

Execution of DP equipment qualification, process and cleaning validation activities.

Cooperation work with related functional departments such as TS, EMU, QA, QC and Supply chain etc.. Especially with EMU to ensure the equipment's reliability.

Ensure the operation in clean room incl. aseptic area with cGMP and procedures in-house compliance.

Report adverse event RFT and participate to investigations, commitments, and change controls to ensure changes are value added and processes and equipment are robust.

Execute CAPA and continuous improvement. Drive changes that support RFT, efficiency, and/or reduced costs.

Develop programs and strategies for real time process monitoring and RFT.

Provide audit support as SME

Ensure DP operation following QEHS regulations

Provide support to DS operation at startup and when needed.

Execute other items assigned by supervisor.

BS or MS in pharmacy, chemical engineering, biology, biochemistry or other related science or engineering field

Familiarity and experience with solution formulation, aseptic operation, lyphilization

Familiarity and experience with a GMP manufacturing environment desirable.

Previous experience with managing or execution of equipments qualification and process validation desirable.

Previous experience with manufacturing-aseptic operation , autoclave, VHP, isolator and filling line, freeze drying and packaging. is highly desirable.Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus

Enterprise Systems familiarity preferred, namely LabWare LIMS, SAP, TrackWise, PDOCS and EAMS

Previous leadership skills a plus.

Good communication skill in both Engligh and Chinese.P: Plant No Clock - (China)

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