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 in writing SOPs for equipment maintenance and operational procedures.
Assist lower labor grades as needed to insure the completion of daily tasks.
Prepare, review and audit for completion and accuracy all assigned records, calibration, and documentation in assigned area to ensure regulatory compliance is maintained.
Collect and help analyze production data on process cultures necessary for determination of acceptability for continued processing.
Assist in determining when culture conditions are appropriate for harvest.
Propose modifications to procedures, equipment, facilities and documentation to improve overall efficiency of operations.
Assist staff in interpreting all process indicators, controls, and PLC controllers in assigned department.
Perform duties in cell culture production and virus roller bottle work centers work centers including BL-3, and will be required to assist staff in others areas as needed.
Required to participate in Equine Encephalomyelitis Program with no health restrictions.
Assist validation group perform departmental equipment/process validations as needed.
Perform duties within bioreactor production and aseptic dispensing work centers
Maintain equipment calibration schedules for routine instruments as defined by SOP’s.
Teach aseptic techniques and monitor others to ensure aseptic technique is properly followed in a production environment.
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.
Issue seed stock and initiate seed cultures as specified by Production Management.
Aseptically dispense and transfer samples for QC testing.
Train lower labor grades.
Start-up, operate, monitor, maintain, and assist in troubleshooting all large-scale production equipment in the assigned department such as, but not limited to, bioreactors, harvest tanks, ultrafiltration equipment, and aseptic dispensing equipment.
Interpret all process indicators, controls, and process logic controllers in assigned area.
Monitor the status of bio-security and recommend improvements.
Perform ultra-filtrations, and prepare accurate documentation.
Perform filter integrity testing and prepare accurate documentation.
Perform, monitor, and assist in troubleshooting and analyzing large-scale virus processes such as, but not limited to, inoculation, harvesting, inactivation, and neutralization processes.
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

Requirements

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:
- Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 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 with two people, each handling 35 pounds.
  - 36 L Spinner flasks are lifted up onto hood w/15L media, plus 5L cell suspension, totaling 79 pounds lifted as a two person lift, each handling 40 pounds.
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.

ACKNOWLEDGEMENTThis position description has been designed to indicate the general nature and level of work performed by employees within this >