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Filling Group Leader – Isolator Line – 3rd shift

Req # JR - 053050 Location Bloomington, Indiana, United States Job Category Assembly Jobs Date posted 10/28/2021

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Summary:

The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  The Filling Group leader will provide operation and support of a filing line that utilizes Isolator technology.  They will be responsible for end-to-end processing and be the subject matter expert on the Isolator syringe filling line.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Baxter Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):

  • Delegate, coordinate, and schedule activities of assigned team members.
  • Recommend measures to improve performance and increase efficiency
  • Train and mentor other team members.
  • Troubleshoot process problems and respond to process alarms.
  • Participate on Continuous Improvement teams.
  • Assist in developing/reviewing batch records of new and existing projects.
  • Assist in establishing and orienting new projects for production
  • Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records. 
  • Organize and coordinate general cleaning and sanitizations throughout all filling suites.
  • Identify potential causes and verify/eliminate each one to determine the true root cause behavior

Job Requirements (Education, Experience and Qualifications):

  • High school diploma or GED required.
  • 2 years related experience preferred.
  • Isolator filling technology experience preferred.
  • Knowledge of cGMP manufacturing preferred.
  • Knowledge of basic laboratory and pharmaceutical production equipment including, but not limited to: filling machines, terminal sterilizers, weight scales, pallet wrappers, etc. preferred
  • Knowledge, assembly, and operation of filling machines and filtration systems preferred.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.)
  • There are minimum training requirements for each operator level

Physical / Safety Requirements:

  • Ability to stand for extended periods of time
  • Ability to lift up to 50 pounds
  • Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)
  • Must be able to perform overhead work (ie: sanitizing walls and ceilings)
  • Physical coordination/flexibility to allow gowning for clean room environments
  • Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
  • Dexterity and physical condition to perform some level of repetitive motion tasks
  • Ability to wear respirator usage when product or task requires
  • Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required

#IND-USOPS

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

053050

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