Manufacturing Technician - Fremont, United States - Adientone

Adientone
Adientone
Verified Company
Fremont, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Job Summary

  • Executes fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multiproduct facility.
  • Performs duties under limited supervision and according to standard operating and manufacturing procedures.
  • Executes independently with adequate training noncomplex 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 approriately.
  • 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 procedural zed.

Education:


  • High school degree, entry level position.
  • Associates/bachelor's degree or biotechnology vocational training preferred.
  • Preferable 1 or more years of experience in cGMP regulated industry
  • Ability to concentrate on detailoriented work in a complex technical setup with a Quality and Right the firsttime mindset.
  • Strong written and verbal communication skills.
  • Ability to work with computerbased systems.
  • Ability to work as part of a high performing team and collaborate effectively with staff.

Required Skills:


  • DETAIL ORIENTED
  • MANUFACTURING TECHNICIAN
  • SOP
  • CGMP
  • SOP
S


Additional Skills:


  • MANUFACTURING OPERATIONS
  • SIP
  • OPERATIONS
  • STOCKING
  • BIOTECHNOLOGY
  • BUSINESS INTELLIGENCE
  • MAINTENANCE
  • FERMENTATION
  • SUPPLY CHAIN
  • ENTRY LEVEL
  • EHS
  • SAFETY STANDARDS
  • CELL CULTURE
  • EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS QUALITY ASSURANCE ASSEMBLY QUALITY CONTROL

Job Type:
Contract


Pay:
$ $23.00 per hour


Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Work Location:
In person
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