Principal Automation Engineer

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 DeltaV 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:

• Bachelors 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.

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