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Princ Engineer-Critical Systems

Req #: 1800013N_en
Location: Marion, NC US
Job Category: Quality
Date Posted: 1/9/2018 3:12:50 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.

Position Summary
Responsible for overseeing North Cove’s Critical Systems to include Environmental Air, Process Air, Deionized Water, Distilled Water, Sterilizer Chlorinated Water, Caustic Delivery, and Pest Control.
Job Responsibilities
  • Quality representative and SME (subject matter expert) responsible for Critical Systems.
  • Review/approval of Critical System modification, Critical Work Requests and Extraordinary Maintenance Requests.
  • Responsible for coordination and implementation of critical system projects.
  • Develop proposals and support/execute validations for Critical System processes. Insure completion of all protocols and validations in a timely and appropriate manner.
  • Lead small project teams as needed to accomplish objectives.
  • Prepare, review and revise, as required, SOPs and Specifications.  Write memos, reports, and other appropriate documentation for proper functioning of the department.
  • Study and recommend techniques to improve existing products/processes.  
  • Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, and improve quality.  
  • Assure compliance with company procedures, applicable quality and regulatory requirements and guidance including GLP, QSR, cGMP, USP, and CDR rules. Compliance will keep the department ready for an audit by both internal and external authorities. It is the responsibility of the Principal Quality Laboratory Associate to answer technical questions concerning the department posed by any inspector.

Knowledge, Skill and Abilities
  • Must be able to communicate effectively with managers, peers, and subordinates.
  • Must exhibit strong leadership, organizational and time management skills, and ability to handle multiple tasks.
  • Must demonstrate effectiveness in empowerment, results orientation and task completion.
  • Must possess the ability to lead projects with minimal supervision.
  • Must possess decision-making and technical problem solving skills.
  • Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
  • Must have basic English written and oral communication skills adequate to communicate with other team members.


Qualifications for this role
  • Must have strong inter-personal skills, ability to manage projects, must learn quickly, must be intuitive, self-reliant, and possess excellent analytical skills and leadership ability. 
  • Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
  • Knowledge of MS Office Suite is required.
  • Fluent in English both speaking & writing.
  • Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) preferred.
Education & Experience
  • Bachelor's degree in science, engineering, computer science, or related technical discipline.
  • Minimum three (3) years of experience in a pharmaceutical production or laboratory environment.
  • Experience in current Good Manufacturing or Laboratory Practices, CFR 21 Part 11 regulations, Good Documentation Practices, and other applicable regulations for validated computerized systems preferred.
A Career that Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

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.

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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