Aseptic Technician I

• Perform aseptic gown qualification and maintain the gown qualification at scheduled intervals.
• Participate in the aseptic media simulation at scheduled intervals as per regulatory requirements.
• Perform the tasks of the production operation specific to intermediate aseptic bulk manufacturing (collection and extraction hyaluronic acid (HA) and Aseptic Fluids/bulks and Gels) and Filling.
• Maintain batch record documentation and logs as required by corporations and regulatory agencies.
• Perform cleaning and sanitization of production equipment and classified production space. Prepare equipment, filters, etc. required for production. Assist in process and system validation activities as required.
• Perform product sampling, environmental monitoring, or other related activities as directed.
• Serve as witness to routine unit operational tasks for batch record signing.
• Maintain all associated documentation for operations being performed.
• Demonstrate ability in the application of requisite skills and applied additional skills and acquired knowledge while following established practices and procedures.
• Accommodate production requirements that may require 50+ hour workweeks.
• Perform routine tasks in the areas of Formulation, Filling, and packaging operation.
• Transfer heavy vessels on wheels and autoclave racks on wheels., Description: Title: Aseptic Technician I This job requires working primarily in, 2nd shift, split shift hours, late extended day hours and weekends. Ability to accommodate producti…

• Ability to work with aseptic gown up for about 80% of the shift working hours.
• Ability to offload products off carts and onto pallets; move transfer carts in and out of manufacturing area.
• Ability to stand over intervals of several hours at a time.
• Ability to bend, squat, and reach.
• Ability to lift, push, or pull various amounts of weight.
• Ability to clean and sanitize process equipment and rooms.
• Ability to complete tasks and training in a cGMP environment.
• Ability to work in both individual and team environment.
• Ability to enter into confined Space. (Approx. 1-2 hr./week) as needed., * Perform routine daily and weekly cleaning of manufacturing area.
• Ensure compliance with GMPs and SOPs.
• Take initiative to identify issues, troubleshoot, propose solutions, and keep leads/management informed.
• Possess good documentation skills and attention to detail.
• Basic computer skills preferred.

Qualification And Education:

• 2+ years of related experience in Pharmaceutical Manufacturing with a minimum of 2+ years of experience in a GMP regulated environment.
• Knowledge in CGMP/regulatory compliance.