Address
Form of workJob Description
Shift3rdWork Schedule09:30pm to 06:00am
Fully onsite position- All overnight shift/ 3rd shift
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 HMI s 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 wheelsand 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,
Primary shift for this position is 3rd shift. Business needs may move the candidate to 2nd shift, split shift hours between 2nd shift and 1st shift. 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
" Experience in Manufacturing preferred.
Fully onsite position- All overnight shift/ 3rd shift
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 HMI s 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 wheelsand 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,
Primary shift for this position is 3rd shift. Business needs may move the candidate to 2nd shift, split shift hours between 2nd shift and 1st shift. 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
" Experience in Manufacturing preferred.
