Preparation Production Engineer

Preparation Production Engineer

Thermo Fisher Scientific
3-6 years
Not Specified

Job Description


Job Description :
JOB SUMMARY:
This position is expected to be the Preparation Production Engineer at Hangzhou site. Support Preparation Manager to oversee, manage, and ensure the successful day-to-day operations of Preparation in Drug Product department for the company.
Support Preparation Manager to guarantee the Preparation Operation including thawing/compounding, parts washing/sterilization, material transferring/disinfection and area cleaning/disinfection etc. for the injectable sterile pharmaceuticals is executed safely and timely in conformity to the current SOP and the cGMP normative, safety & environment policy and labor law.
RESPONSIBILITIES:
  • Collaborate effectively with Preparation Operation team, support Preparation Manager in human resource management such as development, coaching, qualification etc..
  • Contribute implementation of facility, equipment, and process improvement projects.
  • Participate in execution and writing of documents (specifications, protocols and reports) related to facility, equipment, and process improvement of production process.
  • Assist conduct IQ, OQ, and PQ for new equipment.
  • Train operators on the operation of the series machines in preparation area.
  • Modification of SOPs and BPRs for new processes in accordance with change control policies.
  • Assist in review BPR, SOP and logbooks for completion and insurance of accuracy of all documents as per GMP guidelines.
  • Contribute &lead in deviation investigations.
  • Implementation of corrective and preventive actions in production.
  • Other tasks assigned by Manager.

Education:
  • Bachelor's degree (MSc preferred)in Pharmaceutical or Biologic Engineering, Life Science related Area.

Experience:
  • At least 3 years of Manufacturing or Quality experience in pharmaceutical companies with Sterile production.

Competencies:
  • Practical knowledge in GMPs and sterile manufacturing process.
  • Extensive background on contamination control such as cleaning, disinfection and sterilization process. Applies GMP regulations and other international guidelines to all aspects of the position.
  • Prior experience in new facility startup and ramp-up is considered an asset.
  • Strong sense of responsibility and prepared to shoulder responsibility.
  • Good command of English and proven IT knowledge.

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