Manufacturing Technician

6 days ago

Fremont, California, United States eTeam Full time
Job Title: Manufacturing Technician I

Location: Fremont, CA

Duration: 6 Months Contract

Shift: Swing Shift/ Sunday -Wednesday/ 02:00 PM-12:30 AM

Duties:

  • Execute fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substances in a multi-product facility. Perform duties under limited supervision and according to standard operating and manufacturing procedures.
  • Execute independently with adequate training in non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging.
  • Perform internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, and recognizing and reporting process and equipment anomalies.
  • Execute 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.
  • Document work according to cGMP and cGDP.
  • Adhere to established regulations and follows cGMP established by site.
  • Report abnormalities and deviations in a timely and accurate manner.
  • Adhere to safety standards and identifies unsafe situations/habits and escalates appropriately.
  • Maintain production areas according to predefined standards (5s).

Skills:

  • Working in a highly regulated environment following all applicable 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 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/bachelor's degree or biotechnology vocational training preferred.
  • Preferable 1 or more years of experience in cGMP regulated industry

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