Manufacturing Technician I

Job Title: Manufacturing Technician I

Location: Fremont, CA

Hours/Schedule: 1st Shift: Mon,Tue,Wed & Sunday, 6:00AM-4:30PM

Type: Contract

Join the leading pharmaceutical company driven by science and seeking to push the boundaries of what's possible in medicine and explore new options in life-enhancing treatments.

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

Skills:

• 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
• 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.

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.

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