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Manufacturing Associate I 2nd Shift

Fremont, CA

Posted: 10/31/2023 Industry: Scientific Job Number: 23-00543

Job Description

2nd Shift: Mon-Fri -- 2: 00PM to 10: 30PM

Duties:

Idependently executes all routine unit operations in Purification including change-over procedures, scheduling within the shift team, equipment cleaning and set up. Able to perform in-process testing such as cell counting, spectrophotometry and environmental monitoring. Monitors and controls weights, flows, volumes, temperatures, pressure, and pH. Identify and report any issues related to manufacturing performance, process and safety to the team lead and assist in investigations of deviations in order to facilitate continuous process improvement. Train junior staff on unit operations such as bioreactors, cell separation, chromatography and tangential flow theory as well as CIP/SIP operations. All training will be conducted with an emphasis on safety and completion of operations in a timely manner. Collaborates within team and department in order to follow best practices and meet department goals. Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement. Responsible for processing in an aseptic clean room environment utilizing virus and cell culture techniques according to USDA regulations Execute processes adhering to the Standard Operating Procedures Complete documentation concurrently Support cross-functional activities as required Responsible for completing assigned tasks (for example, cleaning, work order escalation, etc.) related to departmental functions Perform preventative maintenance and general upkeep on equipment and facilities including environmental monitoring Responsible for maintaining accurate area inventories for raw materials and supplies Adhere to current Good Manufacturing Practice (cGMP)

Skills:

Experience working with established GMP procedures and bulk manufacturing. Technical knowledge of manufacturing systems, methods and procedures. Understanding of purification/cell culture processes. Possess effective troubleshooting skills with equipment and/or process. Computer skills including Microsoft Office (Word, Excel, PowerPoint, etc.) Basic math skills Ability to work in a team atmosphere Ability to communicate effectively (verbal and written) Demonstrated ability to problem solve Will be moving and lifting 45 pound containers regularly

Required Skills:
MES
SAP
BATCH RECORD
PACKAGING
ASSEMBLY
Additional Skills:
OPERATIONS
CGMPS
GMP
SCHEDULING
PROCESS TESTING
CIP/SIP
ASEPTIC
DOCUMENTATION
PROCESS IMPROVEMENT
LABORATORY
MAINTENANCE
FERMENTATION
CHROMATOGRAPHY
TEAM LEAD
MICROSOFT POWERPOINT
CGMP
USDA

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About Fremont, CA

Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!