Principal Engineer: Automation - DeltaV

Role Summary

Automation Principal Engineer providing automation technical leadership to a group of Automation Engineers supporting GMP Drug Substance Plant Operations. Collaborates with capital projects to deliver robust automation systems for a new plant, leveraging diverse automation platforms and ensuring lifecycle management and Operational Excellence.

Responsibilities

• Develop and maintain process control automation solutions using DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), and Building Management Systems (BMS).
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Collaborate with business partners to understand how automation can improve workflow and productivity; synthesize requirements from clients, customers, or end-users to develop the best automation solutions.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.
• Maintain Data Integrity Assessments with current Amgen and Industry standards.
• Build the business processes to support the project scope in alignment with project timelines.
• Provide rotational automation on-call support for manufacturing operations.
• Maintain detailed specification and engineering policies and procedures that affect multiple organizational units.
• Assist in cultivating a robust talent pipeline with diverse capabilities; recruit, coach, develop, empower, and retain staff; ensure an adaptable organizational structure.
• Establish technical training, leadership training, and cross-training plans to continually develop staff and build breadth and depth in the organization.
• Act as an expert resource for helping automation engineering staff develop robust long-term development plans aligned with their aspirations.
• Lead and support functional area projects focused on improving process equipment/utilities/facilities and large capital projects to integrate new drug substance manufacturing technologies.
• Lead/support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
• Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
• Provide day-to-day Operational Support including automation system administration, OS hotfix assessments and rollout, preventative and corrective maintenance, and spare parts management.
• Remain curious and seek innovative ways to improve operations, cost efficiency, and performance.

Qualifications

• Basic Qualifications:
  • High school diploma / GED and 12 years of Manufacturing Automation Engineering experience OR
  • Associate degree and 10 years of Manufacturing Automation Engineering experience OR
  • Bachelor’s degree and 6 years of Manufacturing Automation Engineering experience OR
  • Master’s degree and 4 years of Manufacturing Automation Engineering experience OR
  • Doctorate degree and 2 years of Manufacturing Automation Engineering experience
• Preferred Qualifications:
  • Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering.
  • Direct knowledge of automation design, process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems (e.g., media, harvest, bioreactors, chromatography, vial filtration, ultrafiltration/diafiltration) and integrating various OEM automation software.
  • Extensive understanding of programming, design, installation and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.
  • Experience with Emerson Delta-V DCS system, Process Control Network design including network segregation, and System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
  • Experience with standalone PLC systems and/or Siemens Desigo BAS is beneficial.
  • Ability to interpret and apply GAMPs and GMPs; familiarity with 21 CFR Part 11, ASTM 2500, S88, and S95.
  • Experience in Capital Project Lifecycle Management: conceptual design, scope and cost estimate development, business case development, detailed design, engineering and validation documentation, and project implementation.
  • Hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
  • Experience with continuous improvements enhancing safety, reliability, and productivity in Drug Substance Plant Operations.
  • Strong leadership, technical writing, and communication/presentation skills.