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Union-Agener is seeking a skilled operations professional to operate and maintain equipment in a controlled pharmaceutical environment in Augusta, GA. You will follow FDA/cGMP specs, perform routine cleaning, gowning, and document batch records while supporting safety and quality SOPs.
Responsibilities include monitoring equipment, troubleshooting with engineers, and participating in team activities, with a 12-hour rotating shift schedule and overtime as needed.
Operate and maintain equipment and complete all required documentation under FDA and cGMP specifications
Perform routine cleaning and sanitizations of controlled environment areas.
Manages IPC (in process checks) for release of regulated FDA product.
Perform housekeeping/cleaning to keep the area clean and free of hazards and audit ready.
Operate in a safe and compliant manner and follow all applicable Safety and Quality SOPs.
Must be able to gown and wear gowning in clean room environment.
Record information accurately and legibly per batch records and procedures.
Monitor/Troubleshoot equipment and make recommendations to the Process Engineers, Automation, Leadership or Manager to improve safety, quality, and production.
Identify operating issues; make recommendations based on conditions and implement changes to achieve efficient operating conditions.
Perform in a team-based environment, willing to participate in team activities, serve in leadership roles and be receptive to receiving and giving constructive coaching to team members and management.
The use of good aseptic technique is an expectation when applicable
Minimum of a High School Diploma or GED.
Minimum 3 years of experience in a chemical, pharmaceutical, or related process operation preferred.
Familiar with cGMP’s preferred
Familiar with cleanroom gowning
Familiar with using a computer, specifically Microsoft Word, Excel, Outlook, and SAP.
High level of initiative
Excellent Communications Skills
Able to handle change and additional tasks productively as assigned.
Team-oriented
Interest in joining the Emergency Response Team
Work 12-hour rotating shifts (28 day rotation/7-day off schedule)
Perform and review work in a manufacturing plant environment.
Must be available to work overtime within department and Union Agener policy guidelines to support the business needs.
Able to ascend/descend ladders and stairs
Wear appropriate clean room garments and appropriate personal protective equipment when applicable.
Lift 50lb loads.
Work in various climate/weather conditions associated with a manufacturing plant at any time.
Respond to plant emergencies when required.