Manufacturing Associate

Responsibilities:

• Excellent employment opportunity for a Manufacturing Associate in the Fremont, CA area.
• Independently 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)
  

Experience:

• Required: High School Diploma or (GED)
• Preferred: B.S. in Biology or relevant field, laboratory experience Manufacturing experience
• 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 45lbs containers regularly
• Schedule: Wednesday - Saturday, 9:00PM - 7:30AM
• Required Skills: ENVIRONMENTAL MONITORING, CELL COUNTING, CIP/SIP, ASEPTIC, PROCESS IMPROVEMENT
• Additional Skills: MICROSOFT OFFICE, SCHEDULING, CHROMATOGRAPHY, TEAM LEAD, EXCEL, CGMP, CELL CULTURE, CLEAN ROOM, PROCESS TESTING, USDA, CGMPS, OPERATIONS, DOCUMENTATION, MICROSOFT POWERPOINT, LABORATORY, MAINTENANCE, GMP, FERMENTATION