Senior Manufacturing Associate
3 weeks ago
Senior Manufacturing Associate-Downstream
This is a Temp to Perm situation.
Swing shift: 2pm-12am, W, Th, F, Sat 10 hour days.
On-site in Fremont, CA.
Executes and coordinates unit operations in Downstream manufacturing as assigned 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.
Independently executes complex unit operations including but not limited to chromatography operations, tangential flow filtration, various filtration methods, and process monitoring. May contribute to equipment and process troubleshooting, as needed. Implements continuous improvement projects of low complexity in the production areas.
Executes independently with adequate training fundamental operations:
-CIP/SIP of tanks, transfer lines, and process equipment.
-Buffer preparation and transfer into tanks and disposables.
-Performs In process testing for samples e.g. spectrophotometry, pH, conductivity, and maintenance of analytical equipment.
May contribute to equipment and process troubleshooting, as needed. Implements continuous improvement projects of low complexity in the production areas.
Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
Documents work according to cGMP and cGDP.
Adheres to established regulations and follows cGMP established by site.
Reports abnormalities and deviations in a timely and accurate manner.
Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
Maintains production areas according to predefined standards.
Basic interactions:
Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control
Strong working knowledge of fundamental manufacturing concepts is required. Moderate technical knowledge of biologics operations is preferred.
2 or more years of experience in cGMP regulated industry.
-Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first time mindset.
-Strong written and verbal communication skills.
-Ability to work with computer-based systems and ideally experience with process control systems (e.g. Delta V) and manufacturing execution systems (MES).
-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.
-
Manufacturing Associate
7 days ago
Fremont, United States Asahi Kasei America Inc Full timeThe Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionova is a...
-
Senior Manufacturing Associate
3 weeks ago
Fremont, CA, United States Catalyx Full timeSenior Manufacturing Associate-DownstreamThis is a Temp to Perm situation. Swing shift: 2pm-12am, W, Th, F, Sat 10 hour days.On-site in Fremont, CA.Executes and coordinates unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and...
-
Senior Manufacturing Engineer
4 weeks ago
Fremont, United States Pacific Fusion Full timeAbout Pacific Fusion Pacific Fusion was founded in 2023 with the mission to power the world with abundant, affordable, clean energy.We are rapidly designing and building a pulsed magnetic fusion system to achieve net facility gain (more fusion energy output than stored energy input). In parallel, we are developing the key components required to build...
-
Senior Manager of Manufacturing Engineering
1 month ago
Fremont, California, United States Siemens Industry Software Inc. Full timeJob Title: Senior Manager of Manufacturing EngineeringJob Summary:Siemens Industry Software Inc. is seeking a Senior Manager of Manufacturing Engineering to lead our manufacturing engineering team. The successful candidate will be responsible for managing and leading a team carrying out quality assurance engineering and manufacturing engineering initiatives,...
-
Senior Engineer, Manufacturing Engineering
1 month ago
Fremont, United States The Judge Group Full timeOur client is currently seeking a Senior Engineer, Manufacturing Engineering for a 12 month + contract. \t\t\t \t\t\tMedical device experience is required.Directs and coordinates fabrication, installation, operation, application, maintenance and repair of mechanical or electromechanical machines, equipment, tools, engines and systems. Ensures that quality...
-
Senior Engineer, Manufacturing Engineering
2 months ago
Fremont, United States The Judge Group Full timeOur client is currently seeking a Senior Engineer, Manufacturing Engineering for a 12 month + contract. Medical device experience is required.Directs and coordinates fabrication, installation, operation, application, maintenance and repair of mechanical or electromechanical machines, equipment, tools, engines and systems. Ensures that quality levels and...
-
Senior Manufacturing Engineer
4 weeks ago
Fremont, United States Insight Global Full timeTitle: Manufacturing EngineerLocation: Fremont, CA 94538Shift: Monday, Friday 8am – 5pm PSTOT: YesType: 6 month C2HPR: $55hr – $90hrResponsibilities (What’ll You’ll Do):Collaborate closely with Design Engineering to develop products that lend themselves to streamlined and robust manufacturing methods with industry-best safety, quality, rate and...
-
Senior Manufacturing Planner
3 months ago
Fremont, United States Hyve Solutions Full timeEnsure 100% on-time delivery.Establish build readiness.Maintain efficiency of capacity and customer sizing.Maintain material control and liability for MFG.Forecast future capacity and labor based on customer requirements.Reconcile the MPS to customer PO coverage weekly to ensure that Hyve is not exposed over and above customer PO coverage or other authorized...
-
Senior Manufacturing Engineering Manager
4 months ago
Fremont, United States Hyve Solutions Full time@HYVE Solutions, missions to help customers, business partners, and employees achieve success through shared goals, strategies, resources and technology solutions. 5@HYVE Solutions, missions to help customers, business partners, and employees achieve success through shared goals, strategies, resources and technology solutions. Job Description: Resolve...
-
Manufacturing Engineer
1 month ago
Fremont, California, United States Tesla Full timeJob DescriptionTesla is seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our manufacturing organization, you will be responsible for developing and implementing manufacturing processes and equipment that meet our high-quality standards.Key Responsibilities:Collaborate with cross-functional teams to drive design for...
-
Visionary Leader for Manufacturing Recruitment
1 month ago
Fremont, California, United States Ultimate Staffing Full timeUltimate Staffing is seeking a seasoned Director of Recruiting to spearhead our client's hiring efforts in the manufacturing industry.This is an exciting opportunity to shape the future of hiring at a company that values innovation, collaboration, and a people-first approach.Located in Fremont, open to remote, this role offers a competitive salary range of...
-
Manufacturing Engineer
4 weeks ago
Fremont, United States Insight Global Full timeWe are currently seeking a manufacturing engineer ideally from the auto-motive space, but open to a variety of experience. What to Expect:In addition to developing manufacturing process and assembly strategies, Manufacturing Engineers work with cross-functional teams throughout the entire product lifecycle. You will work closely with Design Engineering,...
-
Manufacturing Technician
6 days ago
Fremont, United States The Mice Groups Full timeManufacturing TechnicianContractOn Site in Fremont, CAPay Range: $20-$39/hourly (W2)Perform functions associated with all manufacturing operations, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, subassemblies and final assemblies. Uses...
-
Manufacturing Technician I
4 weeks ago
Fremont, United States Joulé Full timeJob Title: Manufacturing Technician I Location: Fremont, CA Hours/Schedule: Sun-Wed-2:00PM-12:30AM Compensation: $19.00- $21.12 Type: Contract Overview Join one of the largest pharmaceutical that is driven by science and seek to push the boundaries of what's possible in medicine and explore new options in life-enhancing treatments. ...
-
Senior Process Engineer
1 month ago
Fremont, United States Cynet Systems Full timeJob DescriptionJob DescriptionWe are looking for Senior Process Engineer for our client in Fremont, CAJob Title: Senior Process EngineerJob Location: Fremont, CAJob Type: ContractJob Description:Pay Range: $51.14hr - $56.14hrThe Senior Process Engineer will generally be responsible for processes and operations of medium to high complexity.Evaluate,...
-
Senior Automation Engineer
4 days ago
Fremont, United States Joulé Full timeJob Title: Senior Process Engineer Location: Fremont, CA Hours/Schedule: 1st Shift: 8:00AM-5:00PM Type: Contract Compensation - $50 - $57.50/hr Responsibilities Evaluates, transfers, and implements new processes into company’s Fremont GMP facility for the manufacturing of biopharmaceutical drug substance. Process transfers of internal company...
-
Senior Automation Specialist
4 weeks ago
Fremont, California, United States Joulé Full timeJob Title: Senior Process EngineerApply after reading through all the details and supporting information regarding this job opportunity.Responsibilities:Evaluate, transfer, and implement new processes into the company's Fremont GMP facility for the manufacturing of biopharmaceutical drug substance.Process transfers of internal company products and external...
-
Senior Automation Engineer
19 hours ago
Fremont, United States Joulé Full timeJob Title: Senior Process EngineerApply below after reading through all the details and supporting information regarding this job opportunity. Location: Fremont, CA Hours/Schedule: 1st Shift: 8:00AM-5:00PM Type: Contract Compensation - $50 - $57.50/hr Responsibilities Evaluates, transfers, and implements new processes into company’s Fremont GMP facility...
-
Supplier Quality Engineer
1 week ago
Fremont, United States Quanta Manufacturing Fremont Full timeJob Summary:Provide expertise in Quality Assurance and process improvement tools and methods to targetedfunctions of the organization to support them in their continuous improvement activities. Contribute in the advancement of the organization in Quanta for business prosperity and customer satisfaction. Execute the initiatives of the organization in the...
-
Senior Automation Engineer
3 weeks ago
Fremont, United States System One Holdings, LLC Full timeJob Title: Senior Process Engineer Location: Fremont, CA Hours/Schedule: 1st Shift: 8:00AM-5:00PM Type: Contract Compensation - $50 - $57.50/hr Responsibilities Evaluates, transfers, and implements new processes into company's Fremont GMP facility for the manufacturing of biopharmaceutical drug substance. Process transfers of internal company products and...