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Cleaning Validation Associate III

Req #: 180005HV_en
Location: Bloomington, IN US
Job Category: Quality
Date Posted: 3/15/2018 5:01:13 PM
Baxter International

Description

Summary:
This position is responsible for cleaning validation compliance that meets worldwide regulatory agency requirements, internal company standards/best practices and current industry practices.  This position oversees and executes cleaning validation and documentation activities.  This position reports to the Manager of Technical Services.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
  • Plans and sets direction for the cleaning validation program.
  • Provides direct leadership of the cleaning validation team members. 
  • Mentors and conducts performance management evaluations.
  • Prioritizes team member activities.
  • Maintains and review visual controls
  • Monitors and research industry cleaning validation trends and practices.
  • Participates in internal, client, and regulatory audits.
  • Supports the facility equipment cleaning validation program.
  • Develops equipment cleaning procedures.
  • Creates and maintains standard operating procedures for cleaning validation program.
  • Develops cleaning validation protocols.
  • Conducts or coordinates performance qualification execution for new products.
  • Prepares validation summaries.
  • Makes process improvements and modifications to the cleaning validation program as needed.
  • Performs operator training.
  • Performs investigations as needed.
  • Serves as liaison between Baxter and the customer.
  • Considered a Subject Matter Expert (SME) in cleaning validation.

Qualifications

 

Job Requirements (Education, Experience and Qualifications):
  • Bachelor’s degree required, preferably in a science or engineering-related field
  • Minimum 5 years related experience required, preferably 2 years supervisory experience.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.)
Physical / Safety Requirements
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires sitting for long hours, but may involve walking or standing for periods of time.
  • Must be to gown for Grade C area.
 

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. 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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