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Principal Engineer

Remote / Online - Candidates ideally in
Marion, McDowell County, North Carolina, 28752, USA
Listing for: Baxter Healthcare
Remote/Work from Home position
Listed on 2026-06-26
Job specializations:
  • Engineering
    Quality Engineering, Automation & Mechatronics Engineer, Validation Engineer
Salary/Wage Range or Industry Benchmark: 143333 - 168000 USD Yearly USD 143333.00 168000.00 YEAR
Job Description & How to Apply Below
Location: Marion

This is where
your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Job Location

Marion, NC

Position

Principal Engineer

Position Description

Baxter Healthcare Corporation is seeking a Principal Engineer with the following duties:

  • Responsible for leading complex automation and control system initiatives within a highly regulated pharmaceutical manufacturing environment.
  • Define the technical vision and provide high‑level architectural guidance for automation systems to ensure alignment with business objectives and regulatory requirements.
  • Evaluate, recommend, and integrate advanced technologies—including robotics, data analytics platforms, and proprietary equipment—to enhance manufacturing performance and reliability.
  • Manage full project life cycles, including capital requests, design, development, validation, commissioning, and launch of automation systems in GMP‑regulated environments.
  • Identify, assess, and mitigate technical and project risks; manage external vendors and support negotiation processes when necessary.
  • Ensure all automation and control initiatives comply with Good Manufacturing Practices (GMP), FDA regulations, and 21 CFR Part 11 requirements. Learn, understand, and consistently apply rigorous quality standards, Standard Operating Procedures (SOPs), and cGMP throughout all project activities.
  • Supervise and coordinate the work of engineers and/or technicians assigned to project activities.
  • Provide technical guidance, mentorship, and leadership to support troubleshooting, problem‑solving, and skills development across the engineering team.
Requirements
  • Bachelor’s degree in Engineering or a closely related field plus 5 years of related experience.
  • Will accept any level of experience in the following skills:
    • Assess the current state of the facility and existing production equipment and develop a comprehensive project execution and implementation plan for the installation of new IV bag filling, pouching, and packing automatic/robotic equipment, utilizing established project management methodologies;
    • Plan and Manage capital of long‑term improvement capital expenditure projects $10M and savings $1M;
    • Execute FDA/MoH regulated Change Management using Trackwise8 Management Systems;
    • Use of Value Stream Mapping and Root Cause Analysis to identify improvement opportunities within the IV bag filling, pouching, and packing production lines. Lead targeted process optimization initiatives focused on increasing operational efficiency, enhancing product quality, and reducing scrap;
    • Site SME for automation equipment for IV bags filling, pouching and packing activities within a production plant;
    • Demonstrated familiarity with GMP requirements and experience operating within a highly regulated, controlled environment;
    • Lead and organize multidisciplinary team activities for Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and pharma qualification protocols IQ and OQ;
    • Demonstrated ability to develop comprehensive project approval documentation and deliver presentations to executive level committees with minimal guidance;
    • Manage and oversee the installation of production line serialization systems to ensure compliance with national and international regulatory standards, including EUFMD, DSCSA, and UDI, required for IV bags;
    • Supervise cross‑functional team members, including operations, maintenance controls and validation, for assigned projects within a pharmaceutical setting.
  • 5% remote work allowed.
Compensation and Benefits

Compet…

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