Manufacturing Associate I / II (DP) – 2nd Shift - Aseptic Fill

Kashiv BioSciences, LLC•Chicago, IL

4d•$24 - $34•Onsite

About The Position

The Manufacturing Associate I / II is a regular employee / or contract full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Employees employ aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

Requirements

Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or related preferred
Or an equivalent of 1 – 4 years (for Associate I and II) of industry experience required.
Operation of Autoclave, filling machine, Aseptic techniques, and clean room manufacturing experience is preferred.
Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English.
Excellent interpersonal skills.
The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes.
Ability to work independently, within SOP, prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.
Skills for working with Computer systems, such as: POMS, LIMS, SAP, NetSuite etc.
Operation and understanding of word processing, spreadsheets, and data management
Knowledge of GMP and safety requirements.
Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, stirrer plate, floor scale, peristaltic pump, Weigh Scales, etc.
Must be able to move around the facility to reach various equipment
Physical lifting and shift required for pushing and pulling containers
Must be able to lift at least 25 lbs. Frequent moving of 25-50 lbs. on carts.
Frequent moving of 100-250 lbs. with assistance.
Must be able to stand for long periods of time
Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching.
Frequent repetitive motions.
Manufacturing processes require extensive documentation in accordance with current Good Manufacturing and Good Documentation Practices. Such documentation must be product in a manner that is both neat and legible.
Limited to no travel

Nice To Haves

Operation of Autoclave, filling machine, Aseptic techniques, and clean room manufacturing experience is preferred.

Responsibilities

To take Line Inspection/Line clearance of ISO6, ISO7, and ISO8 areas.
To weigh and dispensing of materials
To operate Part washer, autoclave, filter, and mixing system
To operate Syringe filler and non-viable particle count.
To calibrate and verify pH and conductivity meter, weighing scale.
To standardize and operate peristaltic pump.
To perform filter integrity test.
To involve in formulation and Filtration of drug product
To involve in Aseptic filling activity with good aseptic area behavior.
To clean ISO5 and ISO6 areas as per SOP.
To maintain inventory (Disinfectant solution, gowns, goggles, wipes, etc.).
To verify all raw materials and other consumables.
Responsible of equipment’s assembly, cleaning, sterilization, and operation.
To prepare media and buffer solutions.
Responsible for submission of samples, in-process testing, such as pH, Conductivity, personnel monitoring plates etc.
To submit documents and material request to start batch manufacturing operation to respective department.
To electronically record all the process steps (If required).
To complete Batch Records and other cGMP documentation accurately and in a timely manner.
To remove and dispose of soiled / expired materials from the manufacturing area.
To ensure that the manufacturing areas are maintained within the required conditions for clean room manufacturing.
To report all nonconformance or events that arise during the shift to the Supervisor.
To assist in the transfer of technology from Process Development to cGMP Manufacturing.
To comply with all safety, cGMP and Company policies, practices, and procedures.
To perform other functions (Packaging) as required or assigned.
To comply with all company policies and standards.