Principal Automation Engineer

KBI Biopharma • Durham, NC

2d

About The Position

The Facilities Engineering Department is responsible for all aspects of maintaining the site infrastructure in an active reliable state to support cGMP operations. Facilities Engineering oversees the architectural features of the buildings, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, and Automation for the facility. The Principal Automation Engineer is responsible for providing technical support for ongoing operations by serving as a system owner for facilities automation systems, maintaining the site in a compliant state, and ensuring engineering and quality standards are maintained. Facilities Engineering is responsible for the generation and implementation of change controls, corrective and preventive actions (CAPAs), deviations, and other quality system records. As a part of project execution, the Principal Automation Engineer supports the design, implementation, commissioning, and validation of new systems or the modification of existing systems and serves as a project manager or lead project engineer for multiple concurrent projects. For larger, more complex projects, the Principal Automation Engineer will manage KBI engineering resources by assigning tasks, setting work priorities, and being responsible for project completion. The Principal Automation Engineer will also manage outside contractors as necessary to fulfill their duties.

Requirements

• Bachelor of Science degree in an engineering discipline and a minimum of 15+ years of progressive experience with responsibilities in instrumentation/automation, and controls. This includes the development, implementation, and maintenance of process improvement.
• Minimum 8 years hands on experience with instrumentation and controls equipment including PLCs, HMIs, SCADA systems, and networking equipment.
• 10+ years supporting and leading automation initiatives within cGMP-regulated environments.
• Strong experience with BAS/BMS, EMS, or process automation platforms such as Siemens Insight & Desigo, Rockwell, and PLC/SCADA based systems.
• Extensive hands-on experience with Unicorn, Wonderware, Rockwell Automation FactoryTalk and RSLogix, Siemens Apogee with PPCL, and Open Process Control (OPC).
• Experience with setting up equipment for data collection, transfer, and archival utilizing AVEVA Pi.
• Experience with industrial communication protocols including, but not limited to RS-485, RS-232, Fieldbus, Ethernet/IP, Modbus, and Profibus.
• Experienced with Windows Servers hardware and Microsoft Windows - applications.
• Have strong automation engineering skills and the ability to troubleshoot and make corrections in the field and manufacturing floor.
• Strong understanding of automation system architecture, control logic, alarm logic, and point configuration review for pharmaceutical cGMP environments.
• Experience implementing process improvements within automation and/or technical operations.
• Broad and in-depth knowledge and practical experience of computer and application validation (preferably using GAMP methodology), cGMP, 21 CFR Part 11, EU Annex 11, ISA88, and ASTM E2500.
• Extensive background in generating and reviewing cGMP documentation for protocol development, user requirements, validation test scripts, and CSV/SDLC processes.
• Must have strong organization, interpersonal, oral and written communication skills.
• Must be able to prioritize multiple commitments and technical problems.
• Must have the ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.
• Ability to concisely write reports and to effectively communicate information to 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 required.
• Ability to perform heat load calculations and size utility systems.
• Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity.
• Execution of assigned tasks will require the ability to access hard to reach areas of the facility to include confined spaces, cramped or low ceilings, interstitials, and mechanical rooms.
• Microsoft Office (Word, Excel, PowerPoint, and Project), AutoCAD
• Standard hand tools, power tools, electrical multimeter, large format plotter, computer, telephone, copy and fax machines

Responsibilities

• Providing technical support for ongoing operations by serving as a system owner for facilities automation systems
• Maintaining the site in a compliant state
• Ensuring engineering and quality standards are maintained
• Generation and implementation of change controls, corrective and preventive actions (CAPAs), deviations, and other quality system records
• Supports the design, implementation, commissioning, and validation of new systems or the modification of existing systems
• Serves as a project manager or lead project engineer for multiple concurrent projects
• Manage KBI engineering resources by assigning tasks, setting work priorities, and being responsible for project completion
• Manage outside contractors as necessary to fulfill their duties

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level