Description

To 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 a number of 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, and process logic controllers (PLCs) including SAP.
Assist lower labor grades as needed to insure the completion of daily tasks.
Practice aseptic technique independently.
Perform media fills (process simulation testing) with passing results per applicable SOP
Perform clean room gowning and pass clean room garment validation consecutively.
Prepare disinfectants and sanitizing solutions.
Ability to independently clean and sanitize production equipment, rooms and areas.
Perform aseptic operation using laminar flow systems and environmental monitoring.
Assist in performing environmental monitoring, such as but not limited to, independently placing settling plates and air sampling.
Set-up, operate, maintain and troubleshoot steam sterilizers, capping machines, Building P sterile fill machines, bottle unscramblers, stoppering machines, tray loaders, bottle washers, sterilizing tunnels, equipment washing machines, sterile filtration equipment, WFI Diluent system, L bar sealers, vision systems, inkjets, automatic bundlers, vacuum check equipment as needed.
Perform sterile filtration to fill media and stabilizer solutions aseptically with satisfactory results.
Aseptically gather and transfer samples for QC testing.
Load and unload freeze driers using appropriate aseptic technique.
Perform filter integrity and prepare accurate documentation.
Perform scheduled preventative maintenance.
Assist higher Grade operators 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.
All 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 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
  - Bundles weigh <20#

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.
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.