Aseptic Technician

Pay Range

$25hr - $30hr

• Perform aseptic gown qualification and maintain the gown qualification at schedule interval.
• Participate in the aseptic media simulation at schedule interval as per regulatory requirements.
• Perform 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 acquire additional knowledge while following established practices and procedures.
• Physical demands include standing, meaningful work activities performed while standing.
• Required flexible work schedule due to random start times and production schedules.
• Must accommodate production requirements that may require 50+ hour workweeks and frequent weekend work depending on production demands.
• Independently perform routine tasks in the areas of Formulation, Filling, and packaging operation as needed.
• Transfer heavy vessels on wheels and autoclave racks on wheels.
• Individuals are required to care for their own safety and wellbeing.
• Promote a safe working environment for employees and contractors in the area of responsibility.
• Support all site HSE policies and ensure compliance with local HSE regulations.
• Complete all required HSE training.
• Report all accidents and incidents and support investigations in the area of responsibility.
• Ensure timely closure of HSE actions owned by their departments.

• Perform routine daily and weekly cleaning of manufacturing area.
• Perform to ensure compliance with GMPs and SOPs.
• Receive instructions on assignments with moderate supervision.
• Take initiative to identify issues, troubleshoot, propose solutions, and keep leads/management informed.
• Require good documentation skills and attention to detail.
• Basic computer skills preferred.

• Work with aseptic gown for about 80% of shift working hours.
• Offload products off carts and onto pallets; move transfer carts in and out of manufacturing area.
• Stand for intervals of several hours at a time.
• Bend, squat, and reach.
• Lifts, pushes, or pulls various amounts of weight.
• Clean and sanitize process equipment and rooms.
• Complete tasks and training in a cGMP environment.
• Work in both individual and team environments.
• Enter confined spaces as required.
• Responsibility includes collection and extraction of hyaluronic acid (HA), HA gel manufacturing, buffer and saline production, intermediate bulk manufacturing, filling, inspection, and packaging process for medical device products along with pharmaceutical products.
• Additional responsibilities include cleaning and sanitization of aseptic manufacturing facility and process equipment.