Manufacturing Technician I

2 days ago

Fremont, California, United States System One Full time
Job Title:

Manufacturing Technician I

Location:

Fremont, CA

Hours/Schedule:

Sun-Wed-2:00PM-12:30AM

Compensation:

$19.00- $21.12

Type:

Contract

Overview

System One is seeking a Manufacturing Technician I to join our team in Fremont, CA. As a key member of our production team, you will be responsible for executing fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility.

Responsibilities
  • 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).
Requirements
  • 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.
  • 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
Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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