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Aseptic Manufacturing Associate
Ref No.: 19-06096
Location: Ridgefield, New Jersey
Sunrise System Inc. is currently looking for Aseptic Manufacturing Associate in Ridgefield, NJ with one of our top client.
 
Job Title: Aseptic Manufacturing Associate
Job Id: 19-06096
Location: Ridgefield, NJ 07657
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Summary
  • Performs the tasks of the production operation specific to aseptic manufacturing, filling, and packaging.
  • Under supervision, performs the tasks of the production operation specific to aseptic manufacturing and filling.
  • Maintains batch record documentation and logs as required by corporation and regulatory agencies.
  • Performs cleaning and sanitizing of production equipment and classified production space.
  • Prepares, according to procedures, various stock solutions and buffers as required by the production process. Prepares equipment, glassware, 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.
  • Requires very few, if any of the requisite skills to perform the required tasks of the position at this level.
  • Receives detailed instructions on all work.
  • All activities are closely supervised and work is reviewed upon completion.
  • 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.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Lift up to 30 - 35 pounds.
  • Required to wear respirator and other protective equipment.
  • Employees may be asked to receive vaccinations (i.e. hepatitis B. tetanus) in order to comply with federal and/or state regulations governing the handling of some biological material.
  • The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Clean room environment for the aseptic production of sterile products.
  • Involves work with hazardous materials.
     
  • Independently performs routine tasks in the areas of Formulation and Aseptic Filling.
  • This includes but it is not limited to Operation of equipment while monitoring critical parameters as per procedures.
  • This job will also entail transfer of heavy vessels on wheels and autoclave racks on wheels.
Skills
  • Perform routine Aseptic processing, Aseptic Gowning and daily/ weekly cleaning of manufacturing area.
  • Will serve as witness of routine unit operation tasks for batch record signing.
  • Maintains all associated documentation for operations being performed.
  • Will be assigned various manufacturing tasks and action items as needed.
  • Applies acquired skills while performing the most complex tasks of the position, following established practices and procedures.
  • Demonstrated ability to apply experience to perform equipment troubleshooting.
  • Implements and maintains production schedules based upon information provided.
  • Perform to ensure compliance with GMPs and SOPs.
  • Generally, receives instructions on all assignments with some supervision.
  • Takes initiative to identify issues, troubleshoot, propose solutions, and keep leads/ management informed.
  • 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, majority of the work activities are performed while standing.
  • Ability to offload product 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 stand for longer periods, bend, squat, and reach
  • Ability to lift, push or pull various amounts of weight
  • Based on 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 40+ hour workweeks, including extended day hours and weekend.
  • Core Work hours are 7am to 3:30pm.  
Education
  • Prior Formulation experience and experience working as an Aseptic Production operator is required.
  • Experience 3-6 years
  • Typical minimum education and experience required is AA degree in related discipline and experience working in GMP environment is required. 
Skills and Experience
  • Aseptic
  • Aseptic Processing
  • Aseptic Production
  • Autoclave
  • Clean room 
Additional Skills
  • Documentation
  • GMP
  • Hazardous Materials
  • SOPS
  • Sterile
  • System Validation
  • Batch Record
  • Environmental Monitoring
  • Maintenance
  • Operations
  • Packaging
  • Production Equipment
  • Production Process
  • Sampling
  • Witness 
Contact
Chenchukala Alwar
Direct: 732-313-0243| Email: Chenchukala.A@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com