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Union APU 3 Production Operator LG4

2 months ago

St Joseph, United States Boehringer Ingelheim Full time

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 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 in writing SOPs for equipment maintenance and operational procedures.

  • Assist lower labor grades as needed to insure the completion of daily tasks.

  • 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.

  • Maintain equipment calibration schedules for routine instruments as defined by SOP´s.

  • Teach aseptic techniques and monitor others to assure 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.

  • Perform, analyze, and record yield determinations, such as but not limited to, plate counts, nephlometer and spectrophotometer quantifications.

  • Perform production in-process sterility testing and prepare documentation.

  • Aseptically gather and transfer samples for QC testing.

  • Assist staff in troubleshooting and improving cultivation processes.

  • Perform, monitor, and assist in troubleshooting all media production processes.

  • Start-up, operate, monitor, maintain, and assist in troubleshooting all production equipment in assigned department.

  • Assist staff in interpreting all process indicators, controls, and PLC controllers in assigned department.

  • Monitor the status of bio-security and recommend improvements.

  • Perform concentration processes and prepare accurate documentation.

  • Perform filter integrity testing and prepare accurate documentation.

  • 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

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

  • 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

  • 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.

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.