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Manufacturing Associate Upstream
Avid Bioservices
Tustin, USA
Full-time
Mid · 2+ years experience
Onsite
USD 20.52-27.35 hourly / hour
Discovered 1 weeks ago
BioreactorspH metersVi-CellSartocheck
Free
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BioreactorspH metersVi-Cell
Key Skills for This Role
BioreactorspH metersVi-CellSartocheck
Full Job Posting
- Perform daily monitoring of equipment.
- Operate and maintain cell culture bioreactors (Wave and 100L – 2000L disposable STR/SUB) in batch, fed-batch, and perfusion modes.
- Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 15L spinner flasks performed in a BSC).
- Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, balance, scale, MFCS, Rees, and Delta V.
- Harvest operations - pod filtration, 3M filtration, and TFF system.
- Schedule vendor service appointments for equipment.
- Purchase necessary equipment and associated materials that are needed or low in supply.
- Help create and actively support 5S, Area Improvement, and Safety Team initiatives to ensure a Continuous Improvement culture throughout the department.
- Operate Sartocheck filter integrity testers.
- Maintain cleanroom facility and equipment.
- cGMP Documentation.
- Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms.
- Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling.
- Identify, escalate, and report deviations (IRs/DRs/CAPAs).
- Set up critical new manufacturing processes and equipment.
- Troubleshoot equipment and process issues in collaboration with Facilities (FAC), Manufacturing Sciences and Technology (MSAT), and Validation (VAL) departments.
- Ensure that equipment and material are available as required for each production run.
- Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed.
- Assist in the transfer of technology from PD and MSAT to cGMP Manufacturing.
- Assist with periodic technical and compliance investigations, inspections, and audits.
- Report all unsafe activities to manager and/or Human Resources.
- Participate in proactive team efforts to achieve departmental and company goals.
- Communicate with team members, supervisors, and members of other departments, as appropriate, to assure prompt resolution of problems.
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