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Validation Assoc I

Req #: 180000IM_en
Location: Bloomington, IN US
Job Category: Quality
Date Posted: 1/11/2018 6:59:37 PM
Baxter International


About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.



The Packaging Validation Associate I supports all aspects of the packaging process.  This includes packaging development, equipment validation and general finishing operations.  The position supports Packaging Development including the defining of packaging requirements, materials selection, package design, prototype development, package testing and the development of all related packaging documentation.  It also supports Packaging Validation including packaging equipment design, specification development, installation, qualification, validation and operational support.  This position reports to the Manager, Packaging Validation.

Essential Duties and Responsibilities:
  • Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment
  • Develops Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, Standard Operating Procedures (SOPs), etc.
  • Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)
  • Participates in small project teams, creates timelines, tracks deliverables and communicates status updates to stakeholders.
  • Formulates and recommends validation procedures and technical work in accordance with project and business objectives
  • Utilizes Engineering and Quality tools to solve problems (e.g., FMEA, Design of Experiments)
  • Selects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Component Specifications and Process Assembly Specifications
  • Acts as Change Control Management (CCM) Owner
  • Reviews and approves documents in VDK and TrackWise


Qualifications for this role
  • Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams.
  • Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Trackwise, etc.)
  • Must be able to lift up to 25 lbs.
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires sitting/standing for long hours, but may involve walking or standing for periods of time 
  • Must wear appropriate Personal Protective Equipment as applicable
  • Must fully understand company safety rules and regulations
Education and Experience
  • Bachelor’s degree required, science or engineering related area preferred

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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.

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