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Manufacturing Technician

3 months ago

South Plainfield, United States Medix Full time

Manufacturing Technician

Location: South Plainfield, NJ

Shift: M-F, 7AM to 3:30PM

Pay: $28.85-$36/HR, based on experience

Qualifications:

  • High School Diploma or GED, Bachelors Degree is preferred
  • 3-5 years in pharmaceutical manufacturing, specifically with TFF, Isolators, or Buffers
  • Must have experience in single-use pharmaceutical manufacturing
  • Expertise in filtration and TFF, and/or experience with Clean Rooms and/or Isolators

Responsibilities:

  • Support the preparation of solutions and buffers for manufacturing processes in accordance with relevant SOPs and/or master batch records, adhering to GMP standards.
  • Possess a robust understanding of cGMP principles and apply them effectively.
  • Experience working in ISO 8 and 7 cleanroom environments is required.
  • Expertise in Single-Use technology is preferred.
  • Familiarity with Downstream manufacturing, including depth filtration, TFF, and Final Fill processes.
  • Provide assistance with various production steps as necessary.
  • Participate in the cleaning and sanitization of manufacturing vessels, equipment, and related items.
  • Contribute to the cleaning and sanitization of rooms and fixed equipment within the aseptic production area.
  • Ability to draft SOPs and other GxP documents.
  • Assist in drafting and implementing deviations, investigations, and CAPAs.
  • Perform daily visual and physical checks/calibrations on in-process equipment.
  • Accurately review and document data.
  • Capable of independently setting up and executing projects.
  • Proficient in troubleshooting and maintaining process equipment.
  • Demonstrate leadership qualities.
  • Strong internal and external communication skills.
  • Collaborate effectively within a team environment.
  • Ability to follow both written and verbal instructions.