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Summary of Position
This role has the responsibility for the design, support, and upgrades of manufacturing controls and electrical infrastructure systems in support of radiopharmaceutical and sterile drug product manufacturing processes. The Principal Automation Engineer will work collaboratively in a cross-functional organization with Operations, Project Management, Quality Assurance, and EHS. This role provides technical discipline and leadership required to develop and implement reliable and compliant equipment and processes. Responsible for independently addressing control system upgrades and improvements through process improvements and via the use of capital project execution. Performs electrical/controls design changes; designs, builds, and installs upgrades via capital project execution. Consults vendors, equipment experts, and industry standards to formulate, design, and install equipment upgrades.
Essential Functions
- Provides technical discipline and leadership to implementation and maintenance of process control systems.
- Independently perform controls implementation and capital project execution in accordance with applicable engineering standards.
- Maintain existing automation and computer systems through preventive maintenance, repairs, expansion, system and user administration, and improvements.
- Assess, implement, and revise engineering standards as needed.
- Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s.
- Provide engineering support to manufacturing, such as installing upgrades and new equipment and assisting in equipment troubleshooting.
- Provide engineering support to return equipment to service.
- Support department and site capital budget development through risk-based identification of system upgrades, service plans, etc.
- Support the development of capital project budgets through the estimation of effort, materials, labor, and external services.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Conduct field inspections during the implementation and installation of automation hardware, wiring, and systems.
- All other responsibilities as assigned with or without accommodation.
Requirements
- Bachelor’s Degree in Engineering or related field required.
- 8 or more years of relevant experience supporting manufacturing automation systems required.
- Preferred 5 years experience in FDA or other regulated environments.
- Preferred experience with Pharmaceutical capital project needs.
- Strong evidence and mastery of being a Team contributor.
- Experience interfacing with internal stakeholders and external vendors to determine requirements and implement projects.
- Demonstrates strong interpersonal skills and written and oral communication proficiency, including the ability to maintain composure and professionalism under pressure.
- Work well under tight and conflicting deadlines using time-management, prioritization, and organizational skills.
- Proficiency in Allen Bradley and/or Siemens PLCs, Allen Bradley HMIs, Staubli Robotics, Motor Controls, Cognex Vision Systems, and sensors in industrial and production applications.
- Experienced in fully testing, commissioning, debugging, and error-proofing PLC and HMI applications.
- Well-developed understanding of process control, process automation, and instrumentation.
- Preferred: Working knowledge of 480V/110V power distribution, Security Access, Smoke/Fire Alarm, and Building Management Systems.
- Preferred: Understanding of PLC communication protocols and networking, including Ethernet I/P and DeviceNet.
- Preferred: SQL Database programming, querying, and web server reporting development.
- Preferred: Computer System Validation experience, use of Change Control systems to manage and implement improvements and systems
- Preferred: Experience in project management, including invoicing, financial management, contractor management, capital requests, and documentation.
- Experience fielding support calls from manufacturing to diagnose and resolve issues.
- Proficiency in computer skills and experience with Microsoft Office Suite, etc.
- Ability to remain flexible to accommodate changes in scope and direction.
- Strong problem-solving skills and ability to leverage previous experience.
LSNJN1413119AB_1743781084