Manufacturing Technician II 225 views

Primary Role:
With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products.

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the following

  • Troubleshoot and resolve process related issues
  • Initiate and document minor deviations
  • Execution of critical and routine production operations
  • Perform Batch Record, Log Book and Form Prep requests
  • Enter data in the Laboratory Information Management System (LIMS)
  • Record data into log books
  • Review log book data
  • Sample preparation and testing
  • Propose document revisions
  • Complete required training on time
  • Carry out work in a safe manner, notifying management of safety issues and risks

10%: This individual will manage equipment and support facility related projects by

  • Initiating work orders
  • Assembly and disassembly of process equipment
  • Perform scheduled cleaning of equipment
  • Perform standardization of equipment
  • Support change over activities
  • Execution of equipment and process qualifications as well as validation

10%: Staff Technical Training and Development

  • Meet and maintain training requirements
  • Develop and maintain personal development plan
  • Provide annual performance self-assessment on development plan

Education & Experience Requirements:
Normally requires a high school diploma and 2-4 years related industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience. Biotech Certificate preferred

Other Requirements:Prior experience in the following activities preferred:

  • Process automation
  • Standardization and measurements utilizing bench top equipment. (i.e. pH meter, osmometer, conductivity meter, etc.)
  • Basic Ultra filtration knowledge
  • Basic Cell culture knowledge
  • Process automation
Only candidates can apply for this job.
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