Manufacturing Technician

4 days ago

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

Job Summary:
eTeam is seeking a highly motivated and detail-oriented Manufacturing Technician I to join our team. 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 substances in a multi-product facility.

Responsibilities:
  • Execute fundamental unit operations in Downstream manufacturing, including parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging.
  • Perform internal support duties, including stocking consumables/materials, updating controlled SOP binders, and recognizing and reporting process and equipment anomalies.
  • Execute with oversight of qualified staff fundamental tasks, such as CIP and SIP of tanks, manufacturing equipment, and buffer prep and transfer into tanks and bags.
  • Perform daily analytics and maintenance of analytical equipment.
  • Clean and setup equipment.
  • Document work according to cGMP and cGDP.
  • Adhere to established regulations and follow cGMP established by site.
  • Report abnormalities and deviations in a timely and accurate manner.
  • Adhere to safety standards and identify unsafe situations/habits and escalate appropriately.
  • Maintain production areas according to predefined standards (5s).

Requirements:
  • 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 technical complexity.
  • 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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