Principal Automation Engineer

Position Overview

The Principal Automation Engineer is responsible for designing, maintaining, and enhancing control systems and electrical infrastructure to support radiopharmaceutical and sterile drug production. This role works closely with Operations, Project Management, Quality Assurance, and Environmental Health and Safety teams to ensure reliable, compliant, and efficient systems. The engineer provides technical expertise, leads system upgrades, and manages capital projects to optimize processes and maintain operational excellence.

Key Responsibilities

• Spearhead the design, implementation, and maintenance of process control systems.

• Independently execute control system upgrades and capital projects, adhering to engineering best practices.

• Sustain and enhance automation systems through preventive maintenance, troubleshooting, system expansions, and user management.

• Review and revise engineering standards to align with industry advancements.

• Foster a safe and compliant workplace by following safety protocols and standard operating procedures.

• Support manufacturing operations with equipment upgrades, new installations, and troubleshooting assistance.

• Facilitate rapid restoration of equipment functionality to reduce downtime.

• Contribute to capital budget planning by identifying system improvement needs and service requirements.

• Estimate project budgets, including costs for labor, materials, and external services.

• Ensure adherence to U.S. and international regulatory standards, including FDA, EU, Health Canada, TGA, PIC/S, ISO, USP, NRC, and cGMP.

• Perform on-site inspections during the installation and implementation of automation hardware and systems.

• Undertake additional duties as assigned, with or without accommodation.

Qualifications

• Bachelor’s degree in Engineering or a related field required.

• At least 8 years of experience supporting manufacturing automation systems.

• Preference for 5 years of experience in FDA-regulated or similarly regulated industries.

• Experience with pharmaceutical capital projects is highly desirable.

• Proven ability to collaborate effectively within cross-functional teams.

• Demonstrated experience engaging with internal stakeholders and external vendors to define requirements and deliver projects.

• Excellent interpersonal, written, and verbal communication skills, with the ability to remain calm under pressure.

• Strong ability to manage multiple priorities and meet tight deadlines through effective time management and organization.

• Expertise in PLC programming (e.g., Allen Bradley, Siemens), HMI development (e.g., Allen Bradley), robotics (e.g., Staubli), motor controls, vision systems (e.g., Cognex), and industrial sensors.

• Proficient in testing, commissioning, debugging, and validating PLC and HMI applications.

• Deep understanding of process control, automation, and instrumentation principles.

• Preferred: Knowledge of 480V/110V power distribution, security systems, fire/smoke alarms, and building management systems.

• Preferred: Familiarity with PLC communication protocols, such as Ethernet I/P and DeviceNet.

• Preferred: Experience with SQL database programming, querying, and web-based reporting.

• Preferred: Familiarity with Computer System Validation and Change Control systems for managing system improvements.

• Preferred: Project management experience, including budgeting, contractor oversight, invoicing, and documentation.

• Ability to respond to and resolve manufacturing support requests efficiently.

• Proficiency with Microsoft Office Suite and related software.

• Flexibility to adapt to changing project scopes and priorities.

• Strong problem-solving skills, drawing on experience to address complex challenges.