Manufacturing Associate I

1 month ago


Fremont, California, United States Fladger Assoc. Inc. Full time
Job Description

Fladger Assoc. Inc. is seeking a skilled Manufacturing Associate I to join our team in Fremont, CA. This is a contract position with a duration of 6-24 months and a negotiable rate.

Responsibilities:

  • Prepare various media and stock solutions to support cell culture operations.
  • Follow SOPs to perform routine cleaning activities and maintain equipment.
  • Collect rinse water samples and perform swabs on required equipment.
  • Document operations through the Bio Manufacturing Execution System (BioMES) and maintain accurate records.
  • Perform internal support duties, including stocking consumables and updating controlled SOP binders.
  • Report any issues related to manufacturing performance, process, and safety to the team lead or Manager.
  • Participate in training and development opportunities to gain an understanding of SOPs.
  • Maintain a clean and organized workspace using the 5S organization methodology.

Requirements:

  • High School Diploma or equivalent plus four (4) years of closely related Technical experience.
  • Associate's Degree with a minimum of two (2) years of closely related Technical experience, or a Bachelor's Degree in a Science or Engineering field.
  • Experience working with established GMP procedures and bulk manufacturing.
  • Technical knowledge of manufacturing systems, methods, and procedures.
  • Understanding of cell culture processes.
  • Demonstrated ability to work well in small work groups and assist in trouble shooting activities.
  • Demonstrated mathematical skills and ability to read, comprehend, and follow written instructions.

Preferred Skills:

  • Current Good Manufacturing Practices.
  • Mammalian cell culture.
  • Bio Manufacturing Execution System (BioMES).
  • Process Control System DeltaV.
  • Laboratory Management Information System (LIMS).

Working Conditions:

  • Regularly works under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
  • Requires physical activity, including standing, walking, and occasional lifting up to 25 lbs.


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