Principal Automation Engineer

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; design, build and install upgrades via capital project execution. Consults vendors, equipment experts, and industry standards to formulate, design and install equipment upgrades.

• 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: installation of upgrades, new equipment installation, and assist 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 development of capital project budgets through 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 implementation and installation of automation hardware, wiring, and systems.
• All other responsibilities as assigned with or without accommodation.
  
  

• Bachelor Degree in Engineering or related field required.
• 8 or more years of relevant experience supporting manufacturing automations 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 requirement and implement projects.
• Demonstrates strong interpersonal skills, written and oral communication proficiency, including 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 PLC's, Allen Bradley HMI's, 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 for changes in scope and direction.
• Strong problem-solving skills and ability to leverage previous experience.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.