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Manufacturing Technician

3 months ago

South Plainfield, United States Kashiv BioSciences LLC Full time
  • Provide daily support for all cGMP manufacturing activities. Includes preparation of all solutions, buffers and all activities associated with an aseptic production area, such as room and equipment cleaning and moving equipment as needed. Follows cGMP guidelines at all times. Takes responsibility to be properly trained and helps to ensure that all training records are kept up-to-date.
Requirements

Essential Duties:
  • Assist in preparation of solutions and buffers for the manufacturing process.
  • Complies with all pertinent SOPs and/ or master batch record following GMP guidance.
  • Must have a strong working knowledge and complies with cGMP guidance as applicable.
  • Must have experience working with in ISO 8, 7 environments.
  • Strong background in Single-Use technology.
  • Familiar with Downstream manufacturing, depth filtration, TFF, and Final Fill.
  • Assist with production process steps as needed.
  • Assist with the cleaning/ sanitizing of manufacturing vessels, equipment and other process related items.
  • Assist with cleaning/ sanitizing of rooms and fixed equipment in the aseptic production area.
  • Must be able to write SOPs and other GxP documents.
  • Must be able to assist/ write and implement deviations, investigations, and CAPAs
  • Daily visual and physical checks/ calibrations of all in-process equipment.
  • Review and document data with accuracy.
  • Must be able to setup and execute projects independently.
  • Must be able to troubleshoot and maintain process equipment.
  • Must display leadership characteristics.
  • Must have strong communication skills internal and external to the department.
  • Must be able to work well with a team.
  • Must be able to follow written and or verbal direction.
Education:
  • Associate degree or equivalent professional experience. Bachelor's degree a plus.
Experience:
  • 8-10 years of relevant work experience in Pharma company.
  • High attention to detail.
  • Proven documentation skills.
  • Dedication to production quality.
  • Experience with production planning.
  • Family with equipment calibration techniques.