Senior Automation Engineer

KBI Biopharma•Durham, NC

About The Position

The Facilities Engineering Department maintains site infrastructure in a reliable state to support cGMP operations. It oversees building features, structural and civil systems, biopharmaceutical process and laboratory equipment, HVAC, plant and clean utility systems, electrical power and lighting, and facility automation. The Senior Automation Engineer provides technical support for ongoing operations as the system owner for Facilities automation systems. The role helps maintain a compliant site and uphold engineering and quality standards, including generating and implementing Change Controls, Corrective and Preventive Actions, Deviations, and other quality system records. For projects, the Senior Automation Engineer supports the design, implementation, commissioning, and validation of new systems and modifications to existing systems. The engineer may serve as a project manager or lead project engineer across multiple concurrent projects. For larger and more complex projects, the role manages KBI engineering resources, assigns tasks, sets priorities, and is accountable for project completion. The engineer also manages outside contractors and trades. Project management activities may include defining and adhering to scope, gaining stakeholder agreement, budgeting, scheduling, risk management, procurement, and installation support.

Requirements

  • Bachelor of Science degree in an engineering discipline and at least 8 years of progressively responsible instrumentation/automation development, implementation, and maintenance experience; alternatively, a Bachelor of Science degree and at least 12 years of such experience.
  • At least 5 years of hands-on experience with instrumentation and controls equipment, including PLCs, HMIs, SCADA systems, and networking equipment.
  • Strong automation engineering skills and ability.
  • Fieldbus configuration and management experience, preferably with Profibus, or ability to obtain such experience.
  • Experience with Windows Server hardware and Microsoft Windows applications.
  • Experience writing protocols, test scripts, user requirements, and system design documents.
  • Strong organization, interpersonal, oral communication, and written communication skills.
  • Ability to prioritize multiple commitments and technical problems, shift priorities according to department or facility needs, and remain open to different ideas and approaches.
  • Ability to write concise reports and effectively communicate with executive management, managers, technicians, government agencies, and customers.
  • Ability to apply engineering principles and problem-solving skills to everyday challenges.
  • Strong math and analytical skills, including the ability to perform heat load calculations, size utility systems, and apply mathematical operations to frequency distributions, variance analysis, and reliability and validity determinations.
  • Ability to access hard-to-reach facility areas, including confined spaces, cramped or low-ceiling areas, interstitials, and mechanical rooms.
  • Computer skills with Microsoft Office (Word, Excel, PowerPoint, and Project) and AutoCAD 3.7.
  • Ability to use standard hand tools, power tools, an electrical multimeter, a large-format plotter, a computer, telephone, copy machine, and fax machine.

Nice To Haves

  • Experience with Unicorn, Wonderware, Rockwell Automation FactoryTalk, Rockwell Automation RSLogix, Siemens Apogee, or Open Process Control (OPC).
  • Experience with qualifiable MES systems, such as OSI Pi.
  • Experience with communication protocols including RS-485, RS-232, Ethernet, Modbus, and Profibus.
  • Experience in biopharmaceutical manufacturing.

Responsibilities

  • Direct or support concurrent automation engineering projects, including technical and project management activities for capital and operational projects.
  • Support maintenance oversight of site instrumentation and plant-level automation hardware and software, as well as oversight of Manufacturing Execution Systems, the Building Management System, and the Data Historian.
  • Support Validation with planning and execution of commissioning and validation protocols.
  • Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
  • Develop and maintain standard operating procedures and other procedures for installed systems.
  • Support and comply with engineering standards, drawing controls, project controls, and other procedures and standards needed for department operations; contribute to their creation and maintenance.
  • For larger, more complex projects, manage engineering resources by assigning tasks, setting work priorities, and ensuring project completion.
  • Manage outside contractors and trades.
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