Principal Engineer Job at Baxter (Marion)

Job Description

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide.

Job Responsibility

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
5% remote work allowed

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
time-off benefits such as 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

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Principal Engineer

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