- Performs the tasks of the production operation specific to aseptic manufacturing, filling, and packaging.
location: Ridgefield, New Jersey
job type: Contract
salary: $21.13 - 24.86 per hour
work hours: 7 to 3
- Independently performs the tasks of the production operation specific to aseptic manufacturing.
- 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. Independently performs product sampling, environmental monitoring, or other related activities as directed.
- Provides instructions and guidance to less experienced technicians.
- Independently performs routine tasks and troubleshooting in the areas of Aseptic bulk manufacturing and formulation.
- This includes but it is not limited to weighing component for bulk manufacturing, operations on vessels for fluid and bulk manufacturing (Assembling, loading, mixing, transferring...), filtration, monitoring parameters, troubleshooting equipment issues, parts Sterilization, Environmental monitoring and Vessel CIP/SIP.
- This job will also entail transfer of heavy vessels on wheels and autoclave racks on wheels
- Typical minimum education and experience required is AA degree in related discipline and experience working in GMP environment is required.
- Prior Formulation experience and experience working as an Aseptic Production operator is required. Experience 3-6 years
- Experience working as an Aseptic Production Operator is required.
- Perform routine daily and 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 assisting with formal FMEAs, RAs, CAPAs, CCRs, NCRs, and Action Items as needed. 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 up to 60lbs
- 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 work weekends.
skills: CAPA, GMP (Good Manufacturing Practice), Manufacturing Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.