Manufacturing Technician I

3 days ago

Fremont, California, United States JobRialto Full time
Job Summary:

The Manufacturing Technician I will execute fundamental unit operations in downstream manufacturing related to the production of bulk drug substances in a multi-product facility. This role involves performing tasks under limited supervision, adhering to standard operating and manufacturing procedures while maintaining compliance with cGMP regulations.

Key Responsibilities:
  • Execute fundamental operations such as parts cleaning, weighing and dispensing, equipment preparation, kit assembly, and staging with adequate training.
  • Perform internal support duties, including stocking consumables/materials, updating controlled SOP binders, and discarding expired reagents.
  • Recognize and report process and equipment anomalies to qualified staff.
  • Assist with CIP and SIP of tanks and manufacturing equipment, as well as buffer preparation and transfer into tanks and bags.
  • Conduct daily analytics and maintenance of analytical equipment.
  • Clean and set up equipment according to established protocols.
  • Document work in compliance with cGMP and cGDP standards.
  • Report abnormalities and deviations in a timely and accurate manner.
  • Adhere to safety standards and identify unsafe situations, escalating as necessary.
  • Maintain production areas in accordance with predefined 5S standards.
Skills:
  • Ability to work in a highly regulated environment, following all applicable SOPs, OCPs, and BGSs for cGMP, EHS, and compliance policies.
  • Flexibility to adapt to a 24/7 shift structure with prior notice.
  • Focus on executing repeatable tasks with moderate technical complexity.
  • Basic interaction with Manufacturing Cell Culture, Purification, Compliance, Engineering & Technology, Supply Chain, Quality Assurance, and Quality Control.
  • Strong attention to detail in a complex technical setup, with a Quality First mindset.
  • Excellent written and verbal communication skills.
  • Proficient with computer-based systems and able to read and understand SOPs and work instructions.
  • Ability to collaborate effectively as part of a high-performing team.
Required Qualifications:
  • High school diploma; entry-level position.
  • Associate's or bachelor's degree or biotechnology vocational training preferred.
  • One or more years of experience in a cGMP-regulated industry preferred.
Keywords:
  • Detail-oriented
  • Manufacturing Technician
  • cGMP
  • SOP
  • Biotechnology
  • Quality Assurance
  • Quality Control
  • Safety Standards
Education: High School

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