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Manufacturing Technician II - Technical Services

Emeryville, CA 12345

Posted: 09/09/2022 Employment Type: Contract Job Category: Other Job Number: 499093 Country: United States Is job remote?: No

Job Description

Duties:    
  • Provides Technical Manufacturing Services in a regulated FDA licensed and ISO certified facility, including cross-functional activities associated with production runs in collaboration with all manufacturing groups.
  • The role may include special projects such as process development and validation activities where scientific research principles are applied.
  • Work as part of a team that supports manufacturing operations on the production floor for buffer/media, glass washers, autoclaves, bioreactors, and various other laboratory equipment with varying levels of automation.
  • Executes laboratory operations that include dispensing of chemicals, volumetric and gravimetric measurements, and preparing solutions.
  • Operate a variety of laboratory equipment (pH/conductivity meters, Gravimetric Balances, Autoclaves, and Glasswashers))
  • Understand basic equipment and procedures required for their areas of responsibility well enough to train other technicians
  • Adhere to valid manufacturing procedures and documentation.
  • Performs specific glassware preparations per standard operating procedures (cleaning, washing, sterilizing, and distributing within all manufacturing groups.) 
  • Assists production sustainability through the performance of SAP cycle counting accuracy, reconciliation, reservations, and/or scrapping of expired materials.
  • Deliver quality products and services on time to all customers, internal and external.
  • Responsible for remaining current on training programs in support of manufacturing processes.
  • Abides by the Quality Policy while contributing to organizational goals and metrics
Follow regulatory requirements:
  • Documentation: Maintains logbooks, inventory forms, SOPs, equipment, on-the-job training forms, and other records as required.
  • Performs legible, clear, and concise data entry into batch records, logbooks, and all other controlled forms used in a cGMP process.
 

NOTE:   For the right candidate the potential for conversion is possible.

Skills:    
  • Complies with cGMP and ISO requirements.
  • Understands basic procedures required for their responsibilities.
  • Maintains accurate documentation in related to manufacturing process.
  • Demonstrates leadership skills to train and guide fellow associates.
  • Understands concepts involving a variety of lab equipment (pH meters, gravimetric balances, autoclaves, and glasswashers)
  • Very good verbal and written communication skill
  • Ability to handle multiple tasks simultaneously
  • Requires math and computer skills including ability to use a calculator to perform basic statistical functions.
  • Understands basic computer applications MS Word, Excel, PowerPoint
  • At least 1 year experience with a AA, AS in a GMP environment
  • Must have knowledge of reagent/buffer preparation processes
  • Experience following and writing SOPs
  • Computer knowledge required with experience using MS Word and Excel
  • Strong attention to detail able to document work accurately, and excellent organizational skills 
  • Experience in project management is desirable
  • Knowledge in SAP is desirable
Occupational Demands
  • Able to lift and push up to 50 lbs. (with assistance)
NOTE:   Notification of Hep B Vaccine required.

            Vision Testing required (color, acuity)

Education:    
At minimum Associate degree or Completion of certified biotech program with a Biotech Certificate of Achievement and/or Biotechnology A.S degree
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