Job Information
Boehringer Ingelheim UNION Aseptic Filling Operator LG4 2nd Shift Mon-Fri 2:00pm to 10:30pm in St. Joseph, Missouri
Description
To perform duties in the manufacturer of high quality biological products.
Duties & Responsibilities
Prepare, review and audit for completion and accuracy all assigned records, calibration, and documentation in assigned area to ensure regulatory compliance is maintained.
Read and follow schedules, procedures, and documents.
Assist in training other employees in an area of responsibility as assigned.
Assist staff in developing new procedures and methods or improving old ones.
Use and understand computer assisted data entry including MES, SAP, scanners, printers, scales and other integrated equipment.
Assist lower labor grades as needed to insure the completion of daily tasks.
Assist validation group perform department equipment validations needed
Start-up, operate, monitor, maintain, and assist in troubleshooting of all production equipment in assigned department including the EU Building B fillers and all department lyos.
Maintain equipment calibration schedules for routine instruments as defined by SOP’s.
Teach aseptic techniques and monitor others to assure aseptic technique is properly followed in a production environment.
Evaluate and teach the pre-requisites for pre-sterile filling activities, such as but not limited to, component sterilization, verification of component sterilization, equipment cleaning, room cleaning, room monitoring including air flows from HEPA filters, room pressures, set-up, equipment sterilization.
Check the availability of all items required to maintain schedules, procedures, and documentation.
Perform housekeeping and safety inspections and issue reports of said inspections.
Assist in the transfer of new products, new test methods, new production processes, and new technology.
Aseptically gather and transfer samples for QC testing.
Interpret all process indicators, controls, and PLC controllers in assigned department.
Monitor the status of bio-security and recommend improvements.
Perform filter integrity testing and prepare accurate documentation.
Perform scheduled preventative maintenance
Assist technician under supervision
Required to perform work of a lower classification as needed.
All personnel will be required to routinely go through an aseptic qualification program to ensure adequate aseptic techniques and behavior.
Other duties as assigned
Desired Skills, Experience and Abilities:
Additional Education and/or Equivalent Experience
Successful completion of National Career Readiness Work Keys assessment
Knowledge of Hazardous Waste Handling
Knowledge of Decontamination and Sterilization
Knowledge of Traffic Patterns
Knowledge of or evidence of working with BPE methods
Understanding of Basic GMP/Documentation practices
Demonstrated ability and understanding of Safe working habits and Material Safety Data Sheets (MSDS)
Understanding of Basic Laboratory Practices, Measurements, Biology and Microbiology
Understanding of operating in an aseptic environment
Ability to work in a team environment
Demonstrated knowledge of Federal, State, and International regulations, such as cGMP, USDA, DOT, EPA, OSHA as they pertain to the employee’s work.
Demonstrated knowledge of corporate guidelines and Policies related to the employee’s work. 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.
Eligibility Requirements
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Requirements
Communication Skills
- Good verbal and written communication skills and ability to train others.
Mathematical Skills
- Perform calculations and conversions involving weights, volumes, and percentages.
Reasoning Ability
Ability to use basic logic to identify and solve problems
Knowledge and skill to recognize creative ideas that add value and are able to be implemented to improve efficiency, effectiveness and reduce complexity for department
Mechanical Aptitude
- Demonstrated understanding of systems, equipment, and processes
Computer Skills
- Experience with Windows Operating System.
Comprehension and application
- Proficient reading, comprehension and application skills toward a diverse set complicated tasks.
Physical Demands
Ability to wear a respirator if required of the job, no pulmonary restrictions.
Sustained heavy lifting over extended periods of time.
LEVEL – III Work related tasks ' weights forces associated:
Pallet of 500 ml bottles on pallet jack-28 lbs (pull), 34.5 pounds (push)
Header tank weighs 43 pounds and is a 2 person lift.
Case of 500 ml bottles-11 lbs, 70 cases per pallet, 10 pallets
Totes are no longer used. Bundles weigh <20#
High school diploma or equivalent
Desired Skills, Experience and Abilities
Additional Education and/or Equivalent Experience
Successful completion of National Career Readiness Work Keys assessment
Knowledge of Hazardous Waste Handling
Knowledge of Decontamination and Sterilization
Knowledge of Traffic Patterns
Knowledge of or evidence of working with BPE methods
Understanding of Basic GMP/Documentation practices
Demonstrated ability and understanding of Safe working habits and Material Safety Data Sheets (MSDS)
Understanding of Basic Laboratory Practices, Measurements, Biology and Microbiology
Understanding of operating in an aseptic environment
Ability to work in a team environment
Demonstrated knowledge of Federal, State, and International regulations, such as cGMP, USDA, DOT, EPA, OSHA as they pertain to the employee’s work.
Demonstrated knowledge of corporate guidelines and Policies related to the employee’s work. 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.
Requirements:Communication Skills
- Good verbal and written communication skills and ability to train others.
Mathematical Skills
- Perform calculations and conversions involving weights, volumes, and percentages.
Reasoning Ability
Ability to use basic logic to identify and solve problems
Knowledge and skill to recognize creative ideas that add value and are able to be implemented to improve efficiency, effectiveness and reduce complexity for department
Mechanical Aptitude
- Demonstrated understanding of systems, equipment, and processes
Computer Skills
- Experience with Windows Operating System.
Comprehension and application
- Proficient reading, comprehension and application skills toward a diverse set complicated tasks.
Physical Demands
Ability to wear a respirator if required of the job, no pulmonary restrictions.
Sustained heavy lifting over extended periods of time.
LEVEL – III Work related tasks ' weights forces associated:
Pallet of 500 ml bottles on pallet jack-28 lbs (pull), 34.5 pounds (push)
Header tank weighs 43 pounds and is a 2 person lift.
Case of 500 ml bottles-11 lbs, 70 cases per pallet, 10 pallets
Totes are no longer used. Bundles weigh <20#
High school diploma or equivalent
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.