Become A Filler Operator

* Complete set up and operation of manufacturing equipment.
* Clean and Sanitize manufacturing related equipment and utensils.
* Stock and sort product for packaging or filling machine operation, and replenish packaging supplies, such as wrapping paper, plastic sheet, boxes, cartons, glue, ink, or labels.
* Document all relative activities associated to the batch in respective equipment logbooks.
* Perform minor preventative maintenance tasks on the equipment.
* Keeps equipment operating by following operating instructions, trouble shooting breakdowns and arranging for repairs.
* Maintains a safe and clean work environment by following current good manufacturing practices (cGMP's), and standard operating procedures; complying with legal regulations.
* Follows established departmental policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental standards

* Clean, set-up, operate and monitor equipment of the production line.
* Complete all required documentation and scheduled quality checks.
* Monitor weights, seals, caps, and general packaging of product.
* Make adjustments to Filler timing and filling, & check mat as needed
* Ability to troubleshoot and resolve basic to moderate operating difficulties
* Collect required samples needed for Quality Assurance testing
* Ensure that the proper packaging materials are used for each product being produced.
* Will have working knowledge and experience with wrapper operations; watching for jams and effectively threading wrap to prevent cost downtime due to handler error.
* Ability to perform filler and filler line changeovers in a safe and efficient matter
* Complete cleaning checklist once line has completed run.
* Prepare equipment for next run to include size changes as needed.
* Maintain a clean, sanitary and safe work area.
* Responsible for adhering to food safety and quality system requirements by committing to meet all pertinent regulatory, customer and SQF requirements.
* Assist in identifying opportunities to improve processes.
* Follow Good Manufacturing Practices.
* Learn and adhere to safety and security policies and procedures.
* Follow all sanitation and quality policies and procedures, and report any deficiencies.
* Performs other duties as assigned

* Set up lines for start of production and selects correct components for use.
* Operates equipment to aseptically fill product containers and continually monitors the process.
* Performs routine process and product inspections.
* Completes all process documentation and communicates to appropriate personnel.
* Manages Components to Support Production.
* Maintains area in orderly and sterile state by removing culls, documenting inspection of the work area, and performing disinfection activities as directed.
* Other duties as directed to include assistance with CIP/SIP.
* Prep, and repack (Pkg.
* Area).
* Process improvement project work.
* Scope of Position:
* The Filling Operator is responsible for controlling the filling line including parameter setup, purging, and running production according to Standard Operating Procedures, Aseptic Technique, Bill of Materials, and Batch Records.
* Operates the Aseptic Filling Process and equipment to aseptically fill solution product into sterilized bottles.
* Monitors and inspects product during the filling process and reacts to issues by making machine and process adjustments, documenting issues, and informing the appropriate personnel of mechanical, electrical, and quality issues.
* Maintains the APA in orderly and aseptic condition by removing culls, documenting inspection of the work area, and performing disinfection activities as directed or required.
* Supports all functions of the APA as needed.
* Hours:
* WE|Saturday,Sunday: 7:00a
* p & Monday,Tuesday: 5:00p
* p
* Key Relationships:
* Operating Procedures, Aseptic Technique, Bill of Materials, and Batch Records

* Responsible for blending and filling serials of antigen.
* Shall have an adequate knowledge of Drug and Chemical names, and be able to distinguish between similar names, physical appearance and precautions in handling.
* Must be able to proceed independently in product processing in accordance with standard methods, standard operating procedures, and Manufacturing Directions, using proper aseptic techniques.
* DUTIES & ESSENTIAL JOB FUNCTIONS
* Manufacturing and compounding sterile solutions and other parenteral classed products.
* Obtaining, weighing, measuring and adding all raw materials as instructed on production procedures.
* Set-up, operate and dismantle for cleaning, all equipment involved in the production process.
* Accurately verify and document identity of all components used in formulation.
* Responsible for assembling antigens into final product formulations and preparation of adjuvants or other intermediates.
* Perform inspection and assessment of equipment and material condition prior to use.
* Determine when repair is necessary and follow up with appropriate documentation.
* Sustained heavy lifting over extended periods of time.
* Document operations with strict adherence to cGMP documentation practices.
* Instruct workers of the lower grades as needed.
* Be able to comprehend and follow Standard Operating Procedures/Filling Manufacturing Directions.
* Fill sterile Parenterals and biologicals according to cGMP’s, SOP, and Filling Manufacturing Directions.
* Follow BIVI’s Standard Operating Procedures for the handling of hazardous wastes.
* Recognize documentation deficiencies and bring the deficiencies and required corrections to the supervisors and technicians.
* Blend biological products aseptically to ensure product sterility.
* May be subject to DEA background check.
* Other Duties as Assigned
* Assist higher Grade operators under supervision
* May perform jobs of the lower grades as required
* All personnel will be required to routinely go through an aseptic qualification program to ensure adequate aseptic techniques and behavior
* Req ID:
* BR