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Manufacturing Technician I

Fremont, CA 94555

Posted: 10/08/2024 Employment Type: Contract Job Category: Scientific Job Number: 615176 Is job remote?: No Country: United States

Job Description


Duties:    
  • Executes fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility.  
  • Performs duties under limited supervision and according to standard operating and manufacturing procedures.
  • Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging.
  • Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.  
  • Executes with oversight of qualified staff fundamental tasks as CIP and SIP of  tanks, manufacturing equipment as well as buffer prep and transfer into tanks and bags
  • Daily analytics and maintenance of analytical equipment.
  • Cleaning and setup of equipment.
  • Documents work according to cGMP and cGDP.
  • Adheres to established regulations and follows cGMP established by site.
  • Reports abnormalities and deviations in a timely and accurate manner.
  • Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
  • Maintains production areas according to predefined standards (5s).

Skills:    
  • Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
  • Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.  
  • Low to moderate - strong focus on execution of repeatable tasks with moderate technical complexity. Performing highly proceduralized tasks.  
  • Basic interactions Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control  
  • Does not require extensive technical knowledge of manufacturing operations.
  • Low impact, repeatable, highly proceduralized.
  • Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
  • Strong written and verbal communication skills.
  • Ability to work with computer-based systems.
  • Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
  • Ability to work as part of a high performing team and collaborate effectively with staff.

Education:    
  • High school degree, entry level position.
  • Associates/bachelors degree or biotechnology vocational training preferred.  
  • Preferable 1 or more years of experience in cGMP regulated industry





Pay Rate Range: $20-30/hr depending on experience 
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About Fremont, CA

Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!

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