Manufacturing Associate II

Job type:
on-site
Start:
06/2014
Duration:
n.a
From:
Real Staffing
Place:
Fremont
Date:
06/03/2014
Country:
flag_no USA
project ID:
715475

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Position Summary:

You will be a part of the manufacturing organization and provide hands-on execution of tasks related to the cGMP manufacture of biopharmaceuticals working in bacterial fermentation, purification and/or fill-finish.Essential Functions:

  • Operate in clean room environment.
  • Assist or perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
  • Ensure compliance with established internal control procedures.
  • Troubleshoot equipment and manufacturing processes.
  • Routine assembly/disassembly and cleaning of manufacturing equipment.
  • Assist in the execution of process, equipment and cleaning validation.
  • Write and revise SOP's and Batch Records.
Preferred Experience:

  • 3+ years experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.
  • Hands-on experience in a cGMP environment
  • Hands-on experience with fermentors at 100L scale or greater preferred
  • Hands-on experience with cGMP UF/DF and chromatography equipment preferred.
  • Experience with process development, transfer, and optimization a plus.
  • Experience with execution of validation protocols a plus.
  • Experience working with potent/toxic agents a plus
Preferred Education:

  • Bachelor's degree in biological sciences, chemical engineering or related discipline
Preferred Additional Skills (i.e., Computer):

  • Excellent communications skills and good attention to detail.
  • Ability to work in fast paced, team environment.
  • Ability to handle multiple projects at one time.
  • Basic knowledge of MS Office (Word, Excel, Outlook).
  • Ability to lift 25 pounds and stand for extended periods of time.
  • Flexibility in job responsibilities and scheduling is encouraged to meet business needs.