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Manufacturing Engineer
Holly Springs, NC
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Principal Automation Engineer at CSL Plasma Principal Automation Engineer at CSL Plasma in holly springs, North Carolina Posted in 1 day ago.
Job Description:
Principal Automation Engineer -
Bulk Manufacturing Position Summary:
The Principal Automation Engineer provides technical leadership and subject matter expertise for automation systems supporting bulk manufacturing operations. This role is responsible for ensuring the reliability, availability, compliance, and continuous improvement of process control systems that enable safe and efficient manufacturing. The position serves as a key technical resource for troubleshooting complex automation issues, leading strategic automation initiatives, and supporting 24/7 manufacturing operations through an on-call rotation.
Key Responsibilities:
Manufacturing Automation Support Provide technical leadership and support for automation systems supporting bulk manufacturing operations including Upstream, Downstream, Support, and Utilities process areas. Ensure high availability and reliability of process control systems, including Delta
V DCS, OEM PLC, HMI, PI
historian, and associated infrastructure. Lead troubleshooting and root cause investigations for complex automation, process, and equipment issues impacting production. Partner with Operations, Engineering, Maintenance, Quality, Validation, and IT teams to resolve manufacturing issues and improve system performance. Operational Excellence Monitor and improve automation system performance, reliability, and cybersecurity compliance. Develop and execute automation reliability strategies to minimize downtime and production disruptions. Lead continuous improvement initiatives focused on process optimization, alarm management, operator effectiveness, and system standardization. Analyze trends and manufacturing data to identify opportunities for increased efficiency, capacity, and robustness. Project Leadership Serve as technical lead for automation capital projects and system enhancements. Develop automation architectures, functional specifications, and design standards. Provide oversight of system integrators, vendors, and contractors. Ensure projects are delivered in compliance with GMP, safety, quality, and corporate standards. Compliance and Documentation Maintain automation systems in accordance with GMP requirements and site procedures. Support change control, deviation investigations, CAPA implementation, and regulatory inspections. Review and approve automation documentation such as specifications and test protocols. Ensure systems remain compliant with applicable data integrity, cybersecurity, and validation requirements. On-Call Support Participate in a 24/7 on-call rotation to provide critical automation support for bulk manufacturing operations. Act as escalation point for complex manufacturing automation incidents and lead restoration efforts.
Required Qualifications:
Bachelor's degree in Engineering, Automation, Computer Science, or a related discipline. 5-10+ years of experience supporting automation systems in pharmaceutical, biotechnology, chemical, or related regulated manufacturing environments. Demonstrated expertise in process control systems including DeltaV, PLCs, HMIs, historians, and industrial networking. Strong troubleshooting, root cause analysis, and technical leadership skills. Experience leading cross-functional projects and mentoring engineering teams. Knowledge of GMP regulations, computer system validation, and data integrity requirements. Professional Engineer (PE) license or advanced degree preferred.
