Manufacturing​/Aseptic Technician

The Fountain Group is currently seeking a Manufacturing/Aseptic Technician for a prominent client of ours.

Location:

Ridgefield, NJ.

$30/hr W2

12 months contract – with possible extension based on performance and business needs.

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.

• 2 years of related experience in Pharmaceutical Manufacturing with experience in a GMP regulated environment.
• Knowledge in CGMP/regulatory compliance.
• Perform routine daily and weekly cleaning of manufacturing area.
• 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.

• 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.

• 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 is performed while standing.
• 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.

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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