Manufacturing Technician I

Position Title: Manufacturing Technician I Work Location: Fremont, CA 94555 Assignment Duration: 4 Months Work Schedule: 2nd Shift: Sun-Wed (38 Hours/week) – Sun-Tues 3 PM–1:30 AM; Wed 3 PM–11:30 PM; Hours Per Day: 9.50 | Days Per Week: 4.00 Work Arrangement: Onsite Position Summary 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. Key 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 such as parts cleaning, weighing and dispensing, equipment prep, kit 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 such as CIP and SIP of tanks, manufacturing equipment, buffer prep and transfer into tanks and bags. Conducts daily analytics and maintenance of analytical equipment. Performs cleaning and setup of equipment. Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP guidelines established by site. Reports abnormalities and deviations in a timely and accurate manner. Adheres to safety standards and identifies unsafe situations/habits, escalating appropriately. Maintains production areas according to predefined standards (5S). Qualifications & Experience Working in a highly regulated environment following all applicable organization and Fremont SOPs, OCPs, and BGSs for cGMP, EHS, and compliance policies. Required to work according to given schedules in a 24/7 shift structure with flexibility to adapt schedule upon prior notice. Low to moderate – strong focus on execution of repeatable tasks with moderate technical complexity, performing highly proceduralized tasks. Basic interactions with Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, and Quality Control. Does not require extensive technical knowledge of manufacturing operations; low impact, repeatable, highly proceduralized. High school degree; entry‑level position. Associate’s or bachelor’s degree or biotechnology vocational training preferred. Preferable 1 or more years of experience in a cGMP regulated industry. Ability to concentrate on detail‑oriented work in a complex technical setup with a quality‑first 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. #J-18808-Ljbffr Spectraforce Technologies