Validation Assoc III

  • Company: Baxter
  • Location: Bloomington, Indiana
  • Posted: November 07, 2017
  • Reference ID: 170009H5

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.

Summary :

The Packaging Validation Associate III supports all aspects of Packaging equipment, including packaging equipment design, specification development, installation, qualification, validation and operational support. This role serves as a resource and subject matter expert for Automated Inspection Machine Equipment and High Speed Packaging Equipment. This position reports to the Manager, Packaging Validation.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned) :
  • Identifies and implements necessary changes to Automated Inspection Machines
  • Performs validations of Automated Inspection Machines for Syringes, Vials, and Cartridges, including development of vision files for particle sensors and for inspection cameras
  • Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment
  • Serves as subject matter expert (SME) on Automated Inspection Machine Validations (Eisai machines)
  • Develops Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, etc.
  • Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)
  • Leads large project teams to accomplish project objectives, including creating timelines, tracking deliverables and communicating status updates to key stakeholders
  • Formulates and recommends test 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)
  • Develops and evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Packaging Component Specifications and Packaging Process Assembly Specifications
  • Creates Project timelines and develops all related packaging equipment validation documentation
  • Maintains up to date knowledge of industry requirements and practices as they relate to packaging equipment
  • Participates in internal and external audits
  • Participates in client tours
  • Acts as Change Control Management (CCM) Owner
  • Reviews and Approves FSS, Line Record, Validation and SOP workflows
  • Serves as designee to Manager, Packaging Validation
  • Mentors less experienced team members
  • Authors NCR's and SNCR's

Job Requirements (Education, Experience and Qualifications):
  • Bachelor's Degree required; science or engineering related area preferred
  • Minimum of 5 years' experience in validation-related activities working in a cGMP environment is required
  • 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.)
  • Background in electromechanical operations required
  • Experience in Machine Vision preferred (Cognex software such as Vision Pro or Insight is desirable)
  • Background in validation (IQ/OQ/PQ) including study design, and the development of Protocols, Final Reports, and SOPs etc. preferred
  • Certified Packaging Professional (CPP) certification preferred

Physical / Safety Requirements:
  • 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

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
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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 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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