Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Aseptic Media Prep LG4 will perform duties in the manufacturer of high-quality biological products.

Duties & Responsibilities

• Prepares, reviews and audits for completion and accuracy all assigned records, calibration, and documentation in assigned area to ensure regulatory compliance is maintained.

• Reads and follows schedules, procedures, and documents.

• Assists in training other employees in an area of responsibility as assigned.

• Assists staff in developing new procedures and methods or improving old ones.

• Uses and understands computer assisted data entry including MES, SAP, scanners, printers, scales, and other integrated equipment.

• Assists lower labor grades as needed to insure the completion of daily tasks.

• Assists validation group perform department equipment validations needed.

• Assigns Batch Numbers to the appropriate product and Batch Record.

• Prepares all assigned records, calculations, and documentation, and accurately post completed Batch Record to the appropriate Shop Packet.

• Teaches aseptic techniques and monitors others to assure aseptic technique is properly followed in a production environment.

• Maintains and operates laboratory equipment, such as but not limited to, pH meters, integrity testing units, Operator Interface Terminals (OIT), HMI’s, and osmometer.

• Operates and maintains all laboratory and production equipment including monitoring and properly interpreting all indicators, controls, and PLC controllers.

• Assists staff in troubleshooting equipment problems.

• Assists in the transfer of new products, new test methods, new production processes, and new technology.

• Performs filter integrity testing and prepare accurate documentation.

• Calibrates pH controllers.

• Prepares, sterilizes, dispenses media and solutions, disinfectants, and sanitizing solutions.

• Performs filter sterilization and heat sterilization operations.

• Sterilizes Add cans, tanks, vessels, and equipment using autoclaves, ovens, clean-in-place (CIP), steam-in-place (SIP), steam docking procedures and TOC.

• Sets-up filters for sterilization.

• Aseptically filters medias and solutions into storage containers and properly identify.

• Aseptically pools serum and other solutions into storage containers and properly identify.

• Practices aseptic techniques independently.

• Aseptically dispenses and transfers samples for QC testing.

• Performs aseptic connections to sterile equipment.

• Performs other production related aseptic processes as required.

• Performs Environmental Monitoring.

• Maintains production vessels such as but not limited to pressure hold test, inspect/change gaskets and valves.

• Performs, monitors, and assists in troubleshooting all media processes.

• Weighs out and prepares production media as needed to meet demands of production.

• Uses and understands computer assisted data entry, including SAP.

• Ability to independently clean, prepare, and sterilize production equipment.

• Maintains inventory of raw materials to ensure production needs are met.

• Performs scheduled preventative maintenance.

• Assists 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.

• Performs additional duties as assigned.

Requirements

• High school diploma or equivalent.

• Good verbal and written communication skills and ability to train others.

• Perform calculations and conversions involving weights, volumes, and percentages.

• Ability to use basic logic to identify and solve problems.

• Knowledge and skill to recognize creative ideas that add value and can be implemented to improve efficiency, effectiveness and reduce complexity for department.

• Demonstrated understanding of systems, equipment, and processes.

• Experience with Windows Operating System.

• Proficient reading, comprehension and application skills toward a diverse set complicated tasks.

Preferred:

• 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.

• Ability 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.

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.