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Formulation Group Leader (2nd shift)

Req #: 180005LX_en
Location: Bloomington, IN US
Job Category: Manufacturing
Date Posted: 3/14/2018 11:09:02 AM
Baxter International


The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation 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 Formulation 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):
  • Prepare media and buffer solutions
  • Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
  • Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
  • Monitor and record critical process parameters
  • Complete all relevant paperwork following GDP/GMP guidelines
  • Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
  • Perform sampling using aseptic techniques
  • Participate on Continuous Improvement Teams
  • Train and mentor other team members
  • Write, revise and review pertinent documentation as appropriate
  • Troubleshoot process problems and respond to process alarms
  • Assist with process/equipment validation and data analysis
  • Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion



Job Requirements (Education, Experience and Qualifications):
  • High School Diploma or GED required
  • 2 years related experience preferred
  • Knowledge of current Good Manufacturing Practices and Good Documentation Practices preferred.
  • Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems preferred
  • Proficiency in a variety of mathematical disciplines and ability to work with both the metric and USA standards of measurement required.
  • 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
  • Must be able to gown qualify for Grade A/B areas.


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.

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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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