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Manufacturing Technician

4 months ago

Fremont, United States Fladger Associates Full time

Responsibilities:

- Excellent employment opportunity for a Manufacturing Associate II 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 equivalent 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 45-pound containers regularly
- Schedule: 2nd Shift: Monday-Friday, 2:00PM to 10:30PM
- Required Skills: AUTOMATED EQUIPMENT, MANUFACTURING OPERATIONS, DOCUMENTATION, PACKAGING, ASSEMBLY
- Additional Skills: PROCESS IMPROVEMENT, MAINTENANCE, GMP, TEAM LEAD, CGMPS, OPERATIONS

Schedule:

- Day shift
- Monday to Friday

**Experience**:

- Manufacturing: 1 year (preferred)

Shift availability:

- Day Shift (preferred)

Ability to Commute:

- Fremont, CA 94536 (required)

Ability to Relocate:

- Fremont, CA 94536: Relocate before starting work (required)

Work Location: In person