Sr Principal Engineer

Job Responsibilities

• Provide technical leadership and engineering support to maintenance, manufacturing, quality, validation, and other site functions to improve facility and utility systems while ensuring compliance with Baxter standards, regulatory requirements, and site objectives.
• Support the reliability, performance, and compliance of critical utility systems including Water for Injection (WFI), process air, environmental air systems, HVAC, chilled water, boilers, cooling towers, potable water, steam distribution systems, and electrical infrastructure.
• Lead facilities and utilities projects from concept development through execution, commissioning, qualification, and project closeout.
• Drive continuous improvement efforts focused on reliability, efficiency, sustainability, compliance, and operational excellence.
• Lead the Cleveland site's Lean Energy Management Program and identify opportunities to optimize energy consumption and utility system performance.
• Support Reliability Centered Maintenance (RCM) and Total Productive Maintenance (TPM) initiatives to improve equipment reliability and lifecycle management.
• Partner with maintenance and operations teams to develop proactive maintenance strategies and asset management programs for critical infrastructure.
• Ensure compliance with preventive maintenance requirements, training expectations, documentation standards, quality systems, safety programs, and 6S principles.
• Analyze facility and utility system performance data to identify trends, improve reliability, reduce downtime, and support informed decision-making.
• Provide technical troubleshooting and root cause analysis for complex facility, utility, and infrastructure-related issues.
• Support capital planning activities, including budgeting, financial forecasting, and prioritization of infrastructure investments.
• Foster a positive, inclusive, and high-performing work environment aligned with Baxter's values of Respect, Responsiveness, Courage, and Collaboration.
• Champion Baxter's commitment to patient safety, product quality, and workplace safety by ensuring decisions and actions support these critical priorities.
• Direct and coordinate internal and external resources to achieve project and operational objectives safely, efficiently, and effectively.
• Ensure compliance with all applicable GMP requirements, FDA regulations, corporate policies, SOPs, and industry standards.
• Maintain a clean, organized, and safe work environment through the consistent application of 6S practices.
• Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs), and Current Good Manufacturing Practices (cGMPs).

Knowledge, Skills, and Abilities

• Demonstrated technical leadership skills with the ability to influence cross-functional teams and drive results in a matrixed environment.
• Strong communication and professional writing skills with the ability to effectively engage stakeholders at all organizational levels.
• Proven ability to manage multiple projects, priorities, and deadlines within a fast-paced manufacturing environment.
• Strong troubleshooting and root cause analysis skills with experience supporting mechanical, electrical, and utility systems.
• Working knowledge of regulated manufacturing environments, including FDA, cGMP, quality systems, and validation requirements.
• Proficiency with Microsoft Office applications and enterprise systems such as Maximo, TrackWise, Coupa, CMMS platforms, and related business systems.
• Knowledge of industrial safety programs including Lockout/Tagout (LOTO), Confined Space Entry, Hot Work, Contractor Safety, and Permit-to-Work systems.
• Ability to collaborate across departments to identify, evaluate, and resolve complex facilities and utility-related challenges.
• Working knowledge of Operational Excellence methodologies, including Lean Manufacturing, Six Sigma, TPM, RCM, and continuous improvement tools.
• Strong project management capabilities, including scheduling, budget management, financial tracking, and resource coordination.
• Ability to read and interpret technical drawings, schematics, engineering specifications, and work instructions.
• Effective verbal and written communication skills with the ability to present technical information to both technical and non-technical audiences.

Required Education and Experience

• Bachelor's degree in Engineering required.
• Minimum of 8 years of engineering experience in a regulated manufacturing environment required.
• Minimum of 5 years of experience supporting FDA-regulated manufacturing operations preferred.
• Demonstrated experience leading capital projects, utility systems, infrastructure improvements, or reliability initiatives in a manufacturing environment.
• Experience supporting pharmaceutical, medical device, biotech, or other highly regulated manufacturing operations strongly preferred.
• Experience with HVAC systems, cleanroom environments, WFI generation and distribution systems, boiler operations, energy management programs, and electrical power distribution systems preferred.
• Experience with reliability engineering principles, asset management programs, and preventive maintenance systems preferred.
• Project Management Professional (PMP), Certified Energy Manager (CEM), Lean Six Sigma, or similar certification is a plus.