Manufacturing Technician Job at JobRialto 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-orientedManufacturing TechniciancGMPSOPBiotechnologyQuality AssuranceQuality ControlSafety Standards Education: High School