Principal Engineer

Baxter International Inc. • Marion, NC

6d • $143,333 - $168,000 • Hybrid

About The Position

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 lifecycles, 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.
• 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.

Responsibilities

• Lead 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.
• Evaluate, recommend, and integrate advanced technologies—including robotics, data analytics platforms, and proprietary equipment.
• Manage full project lifecycles, 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.
• Ensure all automation and control initiatives comply with Good Manufacturing Practices (GMP), FDA regulations, and 21 CFR Part 11 requirements.
• 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.
• 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.
• 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.

Benefits

• Comprehensive compensation and benefits packages
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal