DescriptionTo perform duties in the manufacturer of high quality biological products.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.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, microscopes, 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.
Assist in performing the bulking of final product and prepare accurate documentation.
Perform filter integrity testing and prepare accurate documentation.
Calibrate pH controllers.
Prepare, sterilize, and dispense media and solutions.
Perform filter sterilization and heat sterilization operations.
Sterilize fermentors, tanks, vessels, and equipment using autoclaves, clean-in-place (CIP), steam-in-place (SIP).
Aseptically dispense fermentation cultures into storage containers and properly identify.
Set-up filters for sterilization and prepare accurate documentation.
Perform production sterility testing and prepare documentation.
Maintain production vessels such as but not limited to pressure hold test, change O rings, inspect valves, and inspect agitator bearings.
Set-up, operate, clean centrifuges, and prepare accurate documentation.
Set-up, operate, clean, sterilize UF and MF concentrators, and prepare accurate documentation.
Set-up, operate, clean, sterilize emulsifiers, and prepare accurate documentation.
Perform other production related aseptic processes as required.
Aseptically gather and transfer samples for QC testing.
Perform scheduled preventative maintenance.
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.
RequirementsCommunication 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
Work related tasks & weights forces associated:
Empty 800L jacketed tank takes 51.7 lbs break away force moved occasionally.
Filled 1500L subs are now moved with tow trucks.
Any sub moving by hand must be done with a minimum of two people if moving assistance devices are not available.
Various filled wire baskets weighing as much as 44 lbs are handled.
Carboys weighing 50 lbs are lifted onto carts.
Ability to wear a respirator as a requirement of the job, no pulmonary restrictions.
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 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.
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.
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.