Senior Automation Engineer

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Automation Engineer to maintain site infrastructure supporting cGMP operations. The role involves providing technical support, managing automation systems, and ensuring compliance with quality standards.

The ideal candidate should have at least 8 years of experience in instrumentation and automation, with strong expertise in project management across concurrent initiatives. You will also oversee change controls and validation of new systems.

Qualifications

• 8+ years of experience in instrumentation/automation development.
• 5+ years hands-on experience with controls equipment.
• Experience with fieldbus configuration (Profibus preferred).
• Ability to write protocols, test scripts, and system documents.

Responsibilities

• Provide technical support for Facilities automation systems.
• Manage multiple concurrent projects and engineering resources.
• Ensure compliance with engineering and quality standards.
• Develop standard operating procedures for installed systems.

Skills

Automation engineering

Instrumentation and controls experience

Strong communication skills

Problem-solving skills

Project management

Education

Bachelor of Science degree in engineering or related field

Tools

AutoCAD 3.7

PLC

Wonderware

Rockwell Automation FactoryTalk

OSI Pi

Job description

Job Summary

The Facilities Engineering Department is responsible for maintaining site infrastructure in an active reliable state to support cGMP operations. The Senior Automation Engineer will provide technical support, serve as system owner for Facilities automation systems, maintain compliance, ensure engineering and quality standards, and oversee change controls, corrective actions, preventive actions, deviations and other quality system records.

Responsibilities

• Provide technical support for ongoing operations and serve as system owner for Facilities automation systems.
• Generate and implement change controls, corrective actions, preventive actions, deviations, and other quality system records.
• Support design, implementation, commissioning, and validation of new or modified systems.
• Serve as project manager or lead engineer for multiple concurrent projects, assigning tasks, setting priorities, and driving project completion.
• Manage KBI engineering resources, outside contractors, and trades.
• Oversee site instrumentation, plant level automation hardware and software, Manufacturing Execution Systems, Building Management Systems, and Data Historian.
• Plan and execute 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 documentation for installed systems.
• Ensure compliance with engineering, drawing, and project controls.

Qualifications

Minimum requirements:

• Bachelor of Science degree in an engineering discipline and a minimum of 8 years of progressively responsible instrumentation/automation development, implementation, and maintenance activities
• OR Bachelor of Science degree and a minimum of 12 years of progressively responsible instrumentation/automation development, implementation, and maintenance activities
• Minimum 5 years hands‑on experience with instrumentation and controls equipment including PLCs, HMIs, SCADA systems, and networking equipment
• Strong automation engineering skills and ability
• Experience with fieldbus configuration and management (Profibus preferred)
• Experience with Unicorn, Wonderware, Rockwell Automation FactoryTalk, RSLogix, Siemens Apogee, Open Process Control (OPC) preferable
• Experience with qualifiable MES systems such as OSI Pi preferable
• Experience with Windows Servers and Microsoft Windows applications
• Experience with communication protocols including RS-485, RS-232, Ethernet, Modbus and Profibus preferable
• Experience in biopharmaceutical manufacturing preferable
• Ability to write protocols, test scripts, user requirements, and system design documents
• Strong organization, interpersonal, oral and written communication skills
• Ability to prioritize multiple commitments and technical problems
• Flexibility to shift priorities according to changing needs and openness to new ideas

Language, Reasoning, and Math Skills

• Ability to concisely write reports and 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, including heat‑load calculations, sizing of utility systems, and statistical analyses (frequency distribution, variance, reliability/validity)

Physical Demands

Execution of assigned tasks will require the ability to access hard‑to‑reach areas of the facility, including confined spaces, cramped or low ceilings, interstitials, and mechanical rooms.

Computer and Equipment Skills

• Microsoft Office (Word, Excel, PowerPoint, and Project)
• AutoCAD 3.7
• Standard hand tools and power tools
• Electrical multimeter, large‑format plotter, computer, telephone, copy and fax machine

EEO Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.