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.As a Production Operator you will perform duties in the manufacturing of high-quality biological products'

Duties & Responsibilities

Prepare all assigned records, calculations, and documentation.
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.
Maintain and operate laboratory equipment, such as but not limited to, spectrophotometer, centrifuges, pH meters, integrity testing units.
Operate and maintain all production equipment including monitoring and properly interpreting all indicators, controls, and PLC controllers.
Assist in troubleshooting equipment problems.
Perform filter integrity testing and prepare accurate documentation.
Calibrate pH and DO controllers.
Prepare, sterilize, and dispense media and solutions.
Perform filter sterilization and heat sterilization operations.
Clean and sterilize fermenters, tanks, vessels, and equipment using autoclaves, clean-in-place (CIP), steam-in-place (SIP).
Use and understand computer assisted data entry.
Aseptically dispense fermentation/harvest cultures into storage containers and properly identify.
Set-up filters for sterilization and prepare documentation.
Maintain production vessels such as but not limited to pressure hold test, change O-rings, inspect valves and replace valve diaphragms.
Set-up, operate, clean, and sterilize UF and MF concentrators and prepare accurate documentation.
Perform other production related aseptic processes as required.
Perform scheduled preventative maintenance.

OTHER FUNCTIONS AND RESPONSIBILITIES

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.
Other duties as assigned.

Requirements

Education and/or Experience

High school diploma or equivalent

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 of complicated tasks.

Physical Demands

MEDIUM LEVEL 3 – Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to10 pounds of force constantly.
Work related tasks ' weights forces associated: Lifting, push/pull in this dept. does not exceed 50 pounds of force. The heaviest item lifted is a carboy weighing 68 pounds, which is carried w/2 people, each handling 35 pounds. These carboys are carried down the stairs. 50L adcan push/pull taking 43 pounds of force. A 41.5 pound pump is occasionally carried.
Ability to wear a respirator as a requirement of the job, no pulmonary restrictions.

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.