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Manufacturing Specialist II

Careers Integrated Resources Inc Ridgefield, NJ (Onsite) Contractor
Job Title: Manufacturing Specialist II
Job Location: Ridgefield, NJ
Job Duration: 12 Months+


Shift: 2nd Shift
Work Schedule: 02:00 pm to 10:30 pm OR 09:00 pm to 05:30 am

Note:
  • A degree is not necessary but is always helpful.
  • GMP experience is needed to understand the requirements of processing parts used for pharma manufacturing.
  • Aseptic gowning experience.
  • This position will work within a group, and experience working in a team environment helps.
  • Required to wear scrubs throughout the shift and spend the majority of the shift on their feet.
  • This is a fully on-site role.
 
Summary:
  • Prefilled Syringe (PFS) Manufacturing is responsible for fill and finish of prefilled syringe products produced on the site.
  • This includes hyaluronic acid (HA) based medical device products as well as pharmaceutical based products.
  • In support of our main functions, additional responsibilities include cleaning and sanitization of process equipment.
 
Job Responsibilities:
  • 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.
  • Must be able to perform cleaning and sanitizing of production equipment and classified production space.
  • Prepares 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.
  • Performs routine tasks in the areas of Aseptic syringe filling.
  • This includes but it is not limited to Operation of the HMIs on automated syringe fillers, performing format part changeovers, bulk sampling, troubleshooting equipment issues, loading syringes into the filling machine or E-beam, manual weight checks, while monitoring critical parameters during operation.
  • This job will also entail transfer of heavy vessels on wheels and autoclave racks on wheels. Perform routine daily and weekly cleaning of Aseptic and Classified manufacturing rooms.
  • 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 applies 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.
  • 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 50+ hour workweeks, including 2nd shift or split shift hours, extended day hours and weekends.
  • This role requires frequent work on weekends depending on production demands.
 
Job Requirements:
  • 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 bend, squat, and reach
  • Ability to lift, push, or pull various amounts of weight
 
Education & Experience:
  • 1 year of related experience in Pharmaceutical Manufacturing with a minimum of 1 year of experience in a GMP regulated environment.
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Job Snapshot

Employee Type

Contractor

Location

Ridgefield, NJ (Onsite)

Job Type

Manufacturing

Experience

Not Specified

Date Posted

04/18/2025

Job ID

25-44284

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