JobRialto is hiring: Manufacturing Technician in Fremont

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