Aseptic Technician

Aseptic Technician I

Location: Ridgefield, NJ Duration: 12 Months

2nd shift

Job Description

Summary: Aseptic Technician Associate will independently perform the tasks of the aseptic manufacturing operation specific to bulk, and fill manufacturing. This 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 based products. In support of our main functions, additional responsibilities include cleaning and sanitization of aseptic manufacturing facility and process equipment.

Job Responsibilities

• 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.
• Performs 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.
• Maintains batch record documentation and logs as required by corporations and regulatory agencies. Must be able to perform cleaning and sanitize production equipment and classified production space. Prepare equipment, filters, etc. required for production. Assists in process and system validation activities as required. Performs product sampling, environmental monitoring, or other related activities as directed.
• Serve as witness to routine unit operational tasks for batch record signing. Maintains all associated documentation for operations being performed.
• Demonstrated ability in the application of requisite skills and applied additional skills and acquired knowledge while following established practices and procedures.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Most of the work activities are performed while standing.
• This job requires working primarily in 2nd shift, split shift hours, late extended day hours and weekends. Based on Business needs and production schedules, random and different start time scenarios may occur, so a very flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require 50 hour workweeks. This role requires frequent work on weekends depending on production demands.
• Upon business needs, independently performs routine tasks in the areas of Formulation, Filling, and packaging operation.
• This job will require the transfer of heavy vessels on wheels and autoclave racks on wheels.

HSE

It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility. The individual must support all client and site HSE policies as well as ensure that work performed is compliant with local HSE regulations. Individuals must complete all required HSE training. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

Skills

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

Job Requirements

• 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.

Basic Requirements

• 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.