Aseptic Filling Operator - Cleanroom GMP Technician

Boehringer Ingelheim; Saint Joseph (MO); Presencial; USD 42.000 - 66.000; Jornada completa

Descripción de la vacante

Boehringer Ingelheim is seeking an experienced manufacturing professional in Missouri to support aseptic operations and sterile filling in a compliant, quality-driven environment. The role emphasizes aseptic technique, spore-free culture systems, and adherence to GMP and environmental monitoring while maintaining strict documentation and teamwork.

Responsibilities include preparing records, following procedures, training others, and operating sterilization and fill equipment within a cleanroom

Formación

• Good verbal and written communication skills.
• Perform calculations and conversions involving weights, volumes, and percentages.
• Ability to use basic logic to identify and solve problems.
• Demonstrated understanding of systems, equipment, and processes.

Responsabilidades

• 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 PLCs including SAP.

Conocimientos

Verbal and written communication

Basic logic and problem solving

System/equipment understanding

Windows OS proficiency

Educación

High school diploma or equivalent

Herramientas

SAP

Windows OS

Descripción del empleo

• Perform scheduled preventative maintenance.

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, 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.

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com