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Validation Associate II

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Round Lake

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

80000.00 - 110000.00 USD / Year
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Job Description:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility:

  • Development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes
  • Validation activities include research, protocol writing/execution and final report generation
  • Investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented
  • Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA and client/customer compliance audits
  • Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation
  • Schedule, plan, communicate, and manage documents and follow-up on validation activities
  • Interpret and apply regulatory requirements concerning validation activities
  • Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
  • Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations
  • Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required
  • Serves as a project lead for projects of intermediate scope with cross-functional teams
  • Support regulatory inspections and responses as required
  • Able to prioritize workload and tasks
  • Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations

Requirements:

  • BS Degree in Science, Engineering or Math with 2 or more years of experience
  • Master's Degree with 1 or more years of experience
  • At least 2 years of direct experience with writing and executing validation protocols is preferred
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation
  • Good interpersonal/communication/influencing/negotiation skills
  • Strong project management skills
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
  • Proficient in Microsoft Word and Excel, computer software
  • Some experience with statistical software helpful
  • Direct or indirect industry knowledge
  • Ability to work independently or in teams
  • Physical demands of the position may require the ability to lift materials up to 20 lbs, dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces
  • Must not be allergic to Cephalosporins or Penicillin

Nice to have:

  • Some experience with statistical software helpful
  • Direct or indirect industry knowledge
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays
  • Paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Childcare benefits

Additional Information:

Job Posted:
February 21, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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