Aseptic Technician

Ridgefield, NJ, US • Posted 8 hours ago • Updated 8 hours ago

Contract W2

Contract Corp To Corp

On-site

Depends on Experience

Fitment

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Job Details

Skills

Attention To Detail
Documentation
EHS
Extraction
GMP
Good Manufacturing Practice
HSE
High Availability
Management

Summary

We are looking for Aseptic Technician for our client in Ridgefield, NJ

Job Title: Aseptic Technician

Job Location: Ridgefield, NJ

Job Type: Contract

Job Description:

Pay Range: $25hr - $30hr

Responsibilities:

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.
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.
Demonstrates ability in applying requisite skills and acquired knowledge while following established practices and procedures.
The physical demands described here are representative of those an employee must meet to successfully perform the essential functions of this job.
Most of the work activities are performed while standing.
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 Sanofi and site HSE policies and ensure that work performed complies 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 ofexperience in a GMP regulated environment.
Knowledge in CGMP/regulatory compliance.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10516350
Position Id: NJ_ATSE_0116
Posted 8 hours ago

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Aseptic Technician

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