Associate, Manufacturing I

AbbVie•Irvine, CA

13h•$58,656 - $99,000

About The Position

Performs cGMP manufacturing operations within a biologics production environment, with primary responsibility for upstream processing and buffer preparation activities. Executes routine and non-routine manufacturing operations in accordance with approved batch records, SOPs, safety requirements, and current Good Manufacturing Practices. Operates, monitors, and supports the setup and calibration of process equipment and associated systems in collaboration with technical support personnel. Prepares buffers, solutions, and process materials; performs material transfers, sampling, in-process checks, and related quality activities to support manufacturing execution. Uses systems such as LIMS, SAP, and automated control platforms to document work, collect and evaluate operating data, and verify compliance with procedural and batch requirements. Makes routine adjustments to equipment, materials, or process parameters within defined limits to maintain process control, product quality, and operational efficiency. Supports troubleshooting of equipment and process issues, investigates deviations as assigned, and escalates unusual conditions appropriately. Maintains accurate and complete documentation, including batch records, logs, and electronic entries. Contributes to continuous improvement efforts by identifying opportunities to enhance upstream and buffer preparation processes, strengthen compliance, and improve executional consistency.

Requirements

Bachelor’s Degree or equivalent required.
At least 2-5 years relevant experience with good writing skills.
Working knowledge of media/buffer preparation, cell culture or purification of biological drugs is required.
Computer proficiency.
A working knowledge of safety, quality systems, and current Good Manufacturing Practices is required.
Familiarity with tech transfer processes.
Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner.
Effectively work in a team environment.
Maintain a high level of energy and professionalism on the job.
Build effective working relationships with customers, co-workers, cross-functioned groups, and management.
Basic understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility.

Responsibilities

Perform cGMP manufacturing activities in a biologics production environment, with primary focus on upstream processing and buffer preparation.
Execute routine manufacturing tasks in accordance with approved batch records, SOPs, safety requirements, and current Good Manufacturing Practices.
Prepare buffers, solutions, and process materials; perform material transfers, sampling, and in-process checks to support campaign execution.
Operate, monitor, and support process equipment, including setup and calibration activities with engineering and technical support personnel.
Use systems such as LIMS, SAP, LabX, Pi, SAIS and automated control platforms to document work, review data, and support compliant execution.
Make routine adjustments to equipment, materials, or process parameters within defined limits to maintain process control and product quality.
Transfer methods into Production instructions to support successful execution of scheduled campaigns.
Draft moderate-scope documents, manage review cycles, and support timely completion of deliverables.
Track issues, gather information, analyze moderate-complexity problems, and work with management and senior staff to determine appropriate actions.
Coordinate with other groups, provide status updates, and maintain accurate documentation to support compliance and operational consistency.