Cynet Systems ยท 20 hours ago
Aseptic Technician
Ridgefield, NJ
Full-time
Onsite
Entry, Mid Level
$25/hr - $30/hr
2+ years expCynet Systems is a company specializing in pharmaceutical manufacturing, and they are seeking an Aseptic Technician to perform aseptic gown qualifications and assist in bulk manufacturing processes. The role involves maintaining documentation, ensuring compliance with safety regulations, and supporting production operations in a GMP regulated environment.
EmploymentRecruitingStaffing Agency
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
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 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
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
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
Qualification
Required
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
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 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
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
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
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
Preferred
Basic computer skills preferred
Company
Cynet Systems
Headquartered in Washington DC Metro Area, Cynet Systems is a top talent supplier for companies across North America.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashwani (Ash) M.
Partner and Co-CEO
Nikhil "Nick" Budhiraja
Founder / Co-CEO
Company data provided by crunchbase