Work Location: Allegheny County, Pennsylvania

Summary:

Seeking an experienced Automation Engineer II to oversee and support facility controls and automation systems within a regulated life sciences manufacturing environment. This role is responsible for ensuring reliable operations, compliance, and integration of new assets, while providing technical support and collaborating with cross-functional teams.

Responsibilities:

• Oversee and manage automation and control systems projects throughout their lifecycle, ensuring ongoing compliance and operational readiness.
• Collaborate with Facilities, Engineering, and Operations teams to address project and operational requirements for automated systems.
• Troubleshoot and resolve issues related to facility control and automation systems to optimize manufacturing performance and maintain cGMP compliance.
• Provide daily support, configuration, and development for automation systems, including break/fix activities.
• Maintain and update automation system documentation, standard operating procedures, and deliver technical/user training as needed.
• Lead investigations into automation-related quality events and implement corrective actions to address findings.
• Manage system maintenance activities, including application patching, test plan documentation, and execution of test scripts for automation systems.
• Coordinate with business users to develop operational reports and manage contractors supporting automation projects and maintenance, ensuring adherence to safety and quality standards.

Qualifications:

• Bachelor’s degree in Engineering, Science, or a related technological field.
• 6+ years of experience in a life-science regulated environment with knowledge of regulatory requirements for pharmaceutical applications.
• 4+ years of experience integrating or interfacing equipment to control systems using OPC, Ethernet IP, or similar protocols.
• Hands-on experience with PLCs (such as Allen Bradley & Siemens), SCADA systems (such as Ignition), Batch Operations (S88/S95), OSI Soft Pi Historian, and BMS/BAS (such as Siemens Desigo).
• Experience in control panel and automation hardware/infrastructure design.
• Demonstrated knowledge of 21 CFR Part 11, Annex 11, and GAMP5 standards.
• Experience working in a pharmaceutical manufacturing environment, including gowning procedures; aseptic operations experience is desired.

Published Category: Manufacturing & Technical Operations