Union Blending Operator LG4 M-F 7am-3:30pm

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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The basic purpose of this role is to perform duties in the manufacture 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.
  • Maintains equipment calibration schedules for routine instruments as defined by SOP’s.
  • Teaches aseptic techniques and monitors others to assure aseptic technique is properly followed in a production environment.
  • Evaluates and teaches the pre-requisites for pre-blending activities, such as but not limited to, component sterilization, verification of component sterilization, equipment cleaning, room cleaning, room monitoring including air flows from HEPA filters, room pressures, set-up, equipment sterilization.
  • Checks the availability of all items required to maintain schedules, procedures, and documentation.
  • Verifies serial formulations for accuracy.
  • Performs housekeeping and safety inspections and issue reports of said inspections.
  • Assists in the transfer of new products, new test methods, new production processes, and new technology.
  • Proposes modifications to procedures and documentation to improve overall efficiency of operations.
  • Aseptically gathers and transfers samples for QC testing.
  • Starts-up, operates, monitors, maintains, and assists in troubleshooting all production equipment in assigned department.
  • Interprets all process indicators, controls, and PLC controllers in assigned department.
  • Assists staff in evaluating equipment and facilities for the purpose of developing suggestions for improvements and/or corrective actions.
  • Monitors the status of biosecurity and recommend improvements.
  • Uses commonly available computer programs to include SAP.
  • Performs filter integrity testing and prepare accurate documentation.
  • Conducts inventory counts on specific antigens or components and resolve discrepancies between SAP and actual counts.
  • Performs scheduled preventative maintenance.


OTHER FUNCTIONS AND RESPONSIBILITIES

  • 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.
  • 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.
  • 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.
  • Mechanical Aptitude – Demonstrated understanding of systems, equipment, and processes.
  • Computer Skills – Experience with Windows Operating System.
  • Proficient reading, comprehension, and application skills toward a diverse set complicated task.


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.


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 to 10 pounds of force constantly.
  • Work related tasks and forces associated:
    • Pushing fat boy 200 tanks, 38 pounds of force; carboy moved w/dolly taking less than 50 pounds of force to move.
    • FREEZER FZB2903 having carts full of antigen 10L bags X 14 on cart, with wheels frozen at -40 degrees (as a one person move, the cart could not be moved AT ALL using a force of 65 pounds), HOWEVER, as a 2 person move it took approximately 45 pounds of force X 2 people to move. THIS IS A 2 PERSON MUST IN THE FREEZER. 


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.

Desired Skills, Experience and Abilities