Manufacturing Technician

Fremont, CA

Contract Duration: 12-24 months

Rate: Negotiable

Salary: NA $1.00

Responsibilities:

• Excellent employment opportunity for a Manufacturing Technician in the Fremont, CA area.
• 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). Keeps own training on track and trains other technicians and associates on operations.
• Contributes to Quality activities as investigations and area walk-throughs.

• Education High School Degree, entry level position.
• Associate's/Bachelor's Degree or Biotechnology Vocational training preferred.
• Preferable 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.
• Ability to work as part of a high performing team and collaborate effectively with staff.
• Working in a highly regulated environment following all applicable company and company 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.
• 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.
• Shift: 1st, Sunday to Wednesday. 0600-1630. 10 hours a day.