Manufacturing Operations Specialist

3 weeks ago

Fremont, California, United States JobRialto Full time
Job Summary: JobRialto is seeking a skilled Manufacturing Technician I to 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

  • Manufacturing Operations Specialist

    4 weeks ago

    Fremont, California, United States JobRialto Full time

    Job Summary:We are seeking a skilled Manufacturing Operations Specialist to join our team at JobRialto. As a key member of our purification team, you will be responsible for executing routine unit operations, including change-over procedures, scheduling, equipment cleaning, and setup.Key Responsibilities:Independently execute all routine unit operations in...

  • Manufacturing Equipment Specialist

    4 weeks ago

    Fremont, California, United States Quanta Manufacturing Fremont Full time

    Job Summary:At Quanta Manufacturing Fremont, we are seeking a skilled Fixture Engineer to join our team. The successful candidate will be responsible for designing, developing, and maintaining manufacturing equipment and fixtures to ensure efficient production processes.Duties/Responsibilities:Design and develop manufacturing equipment and fixtures to meet...

  • Manufacturing Operations Specialist

    4 weeks ago

    Fremont, California, United States JobRialto Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Technician to join our team at JobRialto. As a key member of our manufacturing team, you will be responsible for executing routine unit operations in Purification, including change-over procedures, scheduling, equipment cleaning, and setup.You will also be responsible for performing in-process testing,...

  • Manufacturing Operations Specialist

    4 weeks ago

    Fremont, California, United States Astrix Technology Full time

    Job Title: Manufacturing TechnicianJob Summary:We are seeking a highly motivated and detail-oriented Manufacturing Technician to join our team at Astrix Technology. As a key member of our manufacturing team, you will be responsible for executing fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substances in a...

  • Manufacturing Operations Specialist

    4 weeks ago

    Fremont, California, United States JobRialto Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Technician to join our team at JobRialto. The successful candidate will be responsible for executing routine unit operations in Purification, including change-over procedures, scheduling, equipment cleaning, and setup.Key Responsibilities:Independently execute routine unit operations in Purification,...

  • SMT Manufacturing Specialist

    4 weeks ago

    Fremont, California, United States Tesla, Inc. Full time

    As a SMT Manufacturing Specialist at Tesla, Inc., you will be responsible for programming and operating SMT equipment such as Printers, Placers, Oven, AOI and AXI. Your tasks will include assisting in developing and refining manufacturing processes, validating production equipment, and participating in manufacturing trials by preparing coupon-level samples....

  • Manufacturing Operations Specialist

    4 weeks ago

    Fremont, California, United States Cynet Systems Full time

    Job Title: Manufacturing TechnicianJob Summary: We are seeking a highly motivated and detail-oriented Manufacturing Technician to join our team at Cynet Systems. As a key member of our manufacturing team, you will be responsible for executing fundamental unit operations in Downstream manufacturing related to the production of bulk drug substances in a...

  • Manufacturing Operations Specialist

    4 weeks ago

    Fremont, California, United States The Fountain Group Full time

    Job Summary:The Fountain Group is seeking a skilled Manufacturing Technician to join our team in Fremont, CA. This 6-month assignment offers a unique opportunity to gain experience in a multi-product facility and contribute to the manufacturing of bulk drug substance.Key Responsibilities: Execute fundamental unit operations in Downstream manufacturing,...

  • Ink Manufacturing Specialist

    4 weeks ago

    Fremont, California, United States Bloom Energy Full time

    Job Summary:Bloom Energy is seeking a highly skilled Ink Manufacturing Specialist to join its team. This individual will be responsible for safely handling chemicals and materials, manufacturing various inks and pastes, and operating printing machines. The ideal candidate will have a strong background in science or engineering and experience with quality...

  • Manufacturing Operations Compliance Expert

    2 weeks ago

    Fremont, California, United States Catalyx Full time

    Job Description:Catalyx seeks a skilled Compliance Specialist to manage change control records and lead projects in support of Manufacturing Operations. This position will support the monitoring and reporting of deviations, change controls, and improvement projects. The role involves owning and maintaining change control records, CAPAs, and Periodic Review...

  • Manufacturing Operations Specialist

    3 weeks ago

    Fremont, California, United States Adecco Full time

    Job SummaryAdecco is seeking a skilled Manufacturing Technician to join our team. As a key member of our production team, you will be responsible for managing production schedules, ensuring timely completion of orders, and overseeing quality control processes. You will also train new employees on manufacturing procedures and safety protocols, troubleshoot...

  • Manufacturing Engineer

    4 weeks ago

    Fremont, California, United States Tesla Full time

    Job DescriptionJob Title: Manufacturing Engineer - ESD Control SpecialistJob Summary: We are seeking a highly skilled Manufacturing Engineer to join our team at Tesla. As an ESD Control Specialist, you will be responsible for developing and implementing a world-class ESD control program across our global manufacturing operations.Key Responsibilities:Develop...

  • Manufacturing Equipment Specialist

    4 weeks ago

    Fremont, California, United States Path Engineering Full time

    Job SummaryPath Engineering is seeking a skilled Manufacturing Equipment Specialist to join our team. As a key member of our maintenance team, you will be responsible for ensuring the optimal performance of our machinery and equipment.Key ResponsibilitiesRepair and maintain complex machinery and equipmentTroubleshoot and diagnose mechanical issuesPerform...

  • Forklift Operator

    4 weeks ago

    Fremont, California, United States Graham Packaging Full time

    Forklift Operator Job DescriptionGraham Packaging is seeking a skilled Forklift Operator to join our team in Fremont, OH. As a Forklift Operator, you will be responsible for operating a forklift to move materials and products throughout the warehouse and production areas.Key Responsibilities:Operate a forklift to transport materials and products safely and...

  • Manufacturing Operations Coordinator

    3 weeks ago

    Fremont, California, United States Hyve Solutions Full time

    Job Title: Manufacturing Operations PlannerJob Summary:We are seeking a skilled Manufacturing Operations Planner to join our team at Hyve Solutions. As a key member of our operations team, you will be responsible for leading new initiatives to improve asset management and inventory control.Key Responsibilities:Lead a new program to identify, track, and...

  • Manufacturing Operations Planner

    3 weeks ago

    Fremont, California, United States Hyve Solutions Full time

    Job Title: Manufacturing Operations PlannerAt Hyve Solutions, we are seeking a skilled Manufacturing Operations Planner to join our team. As a key member of our operations team, you will play a critical role in supporting new initiatives on asset management and inventory control.Key Responsibilities:Lead a new program to identify, track, and report capital...

  • Manufacturing Technology Specialist

    4 weeks ago

    Fremont, California, United States Hyve Solutions Full time

    Hyve Solutions is seeking a skilled Manufacturing Technology Specialist to join our team. As a key member of our production team, you will be responsible for the set-up, calibration, testing, and troubleshooting of circuits, components, instruments, and mechanical assemblies. Your expertise will be essential in determining and developing test specifications,...

  • Ink Manufacturing Specialist

    4 weeks ago

    Fremont, California, United States Bloom Energy Full time

    Job Title: Ink Manufacturing Technician Job Summary: We are seeking a highly skilled Ink Manufacturing Technician to join our team at Bloom Energy. The successful candidate will be responsible for safely handling chemicals and materials, manufacturing various inks and pastes, and operating printing machines. Key Responsibilities: • Safely handle...

  • Manufacturing Specialist

    4 weeks ago

    Fremont, California, United States Randstad Full time

    Production Operator Job DescriptionRandstad is seeking a skilled Production Operator to join our team. As a Production Operator, you will be responsible for:Key Responsibilities:Pulling the order form to determine the required product for productionPulling the product from the warehouse and delivering it to the production floorPerforming wrapping skids,...

  • Data Center Operations Specialist

    3 weeks ago

    Fremont, California, United States Insight Global Full time

    Job Title: Data Center Operations SpecialistJob Summary:We are seeking a highly skilled Data Center Operations Specialist to join our team at Insight Global. As a Data Center Operations Specialist, you will be responsible for the deployment and operations of CPU's, GPU's, PDU's, and networking within the data center.Key Responsibilities:Deploy and operate...