Principal Engineer

Fresenius Kabi USA, LLC
$90,816 - $130,000 Annually + 10% Bonus
life insurance, 401(k)
United States, New York, Grand Island
3159 Staley Rd (Show on map)
Mar 15, 2025
Job SummaryResponsible for overseeing the development and implementation of efficient manufacturing processes, ensuring product quality, and meeting regulatory requirements. Provides guidance in the design, development, implementation and support of all aspects of electrical control systems, equipment, and machinery related to site utilities, production equipment, and facilities. Is a technical leader and subject matter expert within Engineering, and a resource to the Maintenance and Validation departments to meet all regulatory and company specific policy requirements and to improve plant efficiency, capacity, and capability via continuous improvement and modernization objectives. Responsible for the research, development, design, layout, building, testing, troubleshooting, repairs and improvement of all manufacturing equipment and plant utility systems. Responsible for identifying and implementing improvements to increase equipment efficiency and address equipment obsolescence. Responsible for ensuring the validated state of all equipment, systems and facilities and compliance with all applicable cGMP, OSHA, DEC, EPA and local government regulations. Salary Range: $90,816 - $130,000 Annually + 10% Bonus Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Responsibilities Responsibilities Guides the conceptualization and development of new methodologies, processes, materials, machines, and computerized equipment for a pharmaceutical production environment. Generates innovative solutions to complex problems through technical guidance for the development, implementation, and technical support/ for all on site control systems architecture, Programmable Logic Controllers (PLC), Human-Machine-Interfaces (HMI), and server/industrial IT network infrastructure. Responsible for maintaining complex computerized production and area monitoring systems in a compliant (cGMP/data integrity) validated and operational state including calibration, maintenance, repairs, and hardware/software updates. Responsible for developing and implementing improvements for efficiency, safety and preventing equipment obsolescence. Leads capital improvement projects, including funding requests, acquisition, installation, startup and associated documentation (including Risk Assessments, User Requirement Specifications, Functional Requirement Specifications, Design Specifications/Qualifications, Factory and Site Acceptance Tests, Machinability Studies and Standard Operating Procedures), and other items deemed appropriate by management. Responsible for upgrading Control systems of site utility systems and production equipment associated with formulation, filling/capping, lyophilization, packaging, and warehousing/distribution areas. Responsible for ensuring the validated state of all equipment, systems and facilities and compliance with all applicable cGMP (including data integrity), OSHA, DEC, EPA, ISO and local government regulations. Responsible for developing relationships with key vendors for technical support and for assistance in hardware applications. Networks with key contacts outside own area of expertise. Works without supervision on highly complex projects with extensive latitude for independent judgement. Lead investigations into deviations, non-conformances, and other manufacturing-related issues, developing and implementing corrective and preventive actions as needed. Supervises 0-3 direct reports. May act as advisor to the engineering team, project teams, and plant management to meet schedules and budgets and/or resolve highly complex technical issues. May manage the work efforts of supervisors/individual contributors. Mentor junior engineers and train them on different engineering systems to achieve the company goals. Prepares funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates and schedules. Requirements Bachelor of Science degree in Electrical Engineering or related Engineering field of study, Master's degree preferred in related field of study. Must have a minimum of 8+ years of related experience with at least 1 year of leadership/supervisory responsibility. Experience with leadership and/or supervisory responsibility preferred. Experience in a highly regulated environment preferred. Must have working knowledge of computerized/automated manufacturing equipment, relevant industrial electric codes, and machine controls including Programmable Logic Controllers (PLCs), relay logic, motor controls (VFDs and servo), temperature and pressure controls including PID, thermocouples, RTDs and transducers and operator interfaces (HMI). Must be proficient in reading process & instrumentation drawings (P&IDs), electrical schematics and ladder logic. The role requires strong leadership and communication skills, the ability to collaborate with cross-functional teams, strong technical writing and documentation skills and a deep understanding of cGMP, FDA regulations, and manufacturing processes. Must have clear understanding of analytical troubleshooting. Strong project management and leadership skills. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.