Senior Automation Engineer (pharma)

Insight Global; Durham (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

Insight Global is seeking a Senior Automation Engineer for a large biopharmaceutical client in the RTP area. The Facilities Engineering Department maintains the site infrastructure to support cGMP operations, overseeing HVAC, electrical, automation, and plant utilities.

A Senior Automation Engineer provides technical support as system owner for Facilities automation, ensuring compliance and leading design, implementation, commissioning, and validation of new or modified systems.

Qualifications

• BS in engineering or related field.
• 8+ years in instrumentation/automation development and maintenance.
• 5+ years hands-on with PLCs, HMIs, SCADA, and networking equipment.
• Experience supporting pharmaceutical/biopharmaceutical manufacturing.
• Experience with Windows servers hardware and Windows applications.
• Experience writing protocols, test scripts, user requirements, and system design docs.

Responsibilities

• Direct or support concurrent automation engineering projects for capital and operational work.
• Oversee maintenance of site instrumentation, automation software/hardware, MES, and BMS.
• Support validation planning and execution of commissioning/validation protocols; aid CAPA, Change Control, Deviations, and risk analyses.
• Develop and maintain SOPs and procedures for installed systems.
• Ensure compliance with engineering standards and change control processes.

Skills

Instrumentation & Controls

Automation Engineering

PLC

HMI

SCADA

Networking

cGMP

Documentation

Project Management

Education

Bachelor of Science in Engineering or related field

Tools

Unicorn

Wonderware

Rockwell FactoryTalk

Rockwell RSLogix

Siemens Apogee

OPC

OSIsoft PI

Windows Server / Windows Applications

Job description

• Bachelor of Science Degree in an Engineering or related field
• 8+ years of progressively responsible instrumentation/automation development, implementation, and maintenance activities
• 5+ years hands on experience with instrumentation and controls equipment including PLCs, HMIs, SCADA systems, and networking equipment
• Experience supporting pharmaceutical or biopharmaceutical manufacturing
• Experience with Windows Servers hardware and Microsoft Windows - applications.
• Experience with writing protocols, test scripts, user requirements, and system design documents.

Pluses:

• Experience with Unicorn, Wonderware, Rockwell Automation FactoryTalk, Rockwell Automation RSLogix, Siemens Apogee, Open Process Control (OPC)
• Experience with qualifiable MES systems, such as OSI Pi
• Experience with communication protocols including but not limited to RS-485, RS-232, Ethernet, Modbus & Profibus

Job Description:

Insight Global is seeking a Senior Automation Engineer for a large biopharmaceutical client in the RTP area. 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. A Senior 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 Actions Preventive Actions, Deviations, and other quality system records. As a part of project execution, a Senior Automation Engineer will support the design, implementation, commissioning, and validation of new systems or the modification of existing systems and serve as a project manager or lead project engineer for multiple concurrent projects. For larger, more complex projects, a Senior Automation Engineer will manage engineering resources by assigning tasks, setting work priorities, and being responsible for project completion. A Senior Engineer will also manage outside contractors and trades. Project Management activities may include scope definition, scope adherence, stakeholder agreement, budgeting, scheduling, risk management, procurement, and installation support

Responsibilities:

• Direct or support concurrent automation engineering projects on both technical and project management aspects for capital and operational projects while ensuring their success in meeting their respective objectives.
• Support the maintenance oversight of site instrumentation, plant level automation hard and software, and oversight of the Manufacturing Execution Systems, Building Management System, and Data Historian.
• Support Validation with the 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 necessary for the successful operation of the department as well as the creation and maintenance of the same.