Purification Manufacturing Specialist

1 week ago


Blue River, Wisconsin, United States GroupA Full time

We are seeking a highly skilled Purification Manufacturing Specialist to support the initial start-up and ongoing operations of our facility in New Jersey. This role involves both supporting the facility start-up and executing hands-on cGMP manufacturing operations.

Key Responsibilities:

  • Design review and equipment selection, procurement, and testing
  • Protocol development and execution, including acceptance testing and equipment/automation debugging
  • Technical training and hands-on cGMP operations
  • Follow cGMP procedures to support manufacturing execution and automated recipes
  • Clean-In-Place (CIP) & Steam-In-Place (SIP) operations, buffer preparation & transfers / filtration, and operational and cleaning of chromatography and filtration systems
  • Equipment & process troubleshooting, deviation identification, reporting, and closure, and cGMP procedure development and optimization

Requirements:

  • AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience
  • Experience with design review processes and proficiency in cGMP procedures
  • Experience with Clean-In-Place (CIP) and Steam-In-Place (SIP) systems and ability to safely handle hazardous materials


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