Senior Manufacturing Systems Engineer: Automation - PLC

Role Summary

Senior Manufacturing Systems Engineer: Automation - PLC at Amgen. Provide automation technical leadership to a group of automation engineers supporting GMP Drug Substance Plant Operations. Work with the Facilities & Engineering Automation team and capital projects to deliver robust automation systems for new plant utilities and standalone systems. Lead continuous improvement and lifecycle management of automation solutions in a GxP environment.

Responsibilities

• Develop and maintain automation solutions utilizing various PLCs such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system.
• Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLCs and interface hardware.
• Lead and support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc.
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Lead in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems.
• Collaborate with business partners to understand how standalone systems 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 the current Amgen and Industry standards.
• Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
• Lead and support technical root cause analysis, incident investigations, and troubleshooting on standalone systems.
• 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.
• Lead Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Standalone Systems, Preventative and Corrective Maintenance, and Automation System spare parts management.
• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

Qualifications

• Required: High School Diploma / GED and 10 years of Engineering experience OR
• Required: Associate’s Degree and 8 years of Engineering experience OR
• Required: Bachelor’s Degree and 4 years of Engineering experience OR
• Required: Master’s Degree and 2 years of Engineering experience OR
• Required: Doctorate Degree
• Preferred: Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering.
• Preferred: Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation such as autoclaves, parts washers, clean steam generator, WFI pretreatment RO, WFI stills, filter integrity testers, wastewater treatment systems, and integrating various OEM automation software.
• Preferred: Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies.
• Preferred: Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
• Preferred: Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.
• Preferred: Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
• Preferred: Hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
• Preferred: Experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
• Preferred: The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Preferred: Strong leadership, technical writing, and communication/presentation skills.

Skills

• Strong leadership, technical writing, and communication/presentation skills.