Senior Manufacturing Systems Engineer: Automation

Role Summary

Senior Manufacturing Systems Engineer – Automation. Provide automation technical leadership to a group of automation engineers who build and maintain automation systems and platforms supporting GMP Drug Substance Plant Operations. Work with the Facilities & Engineering Automation team and capital projects to deliver robust process automation for the new plant, integrating lifecycle management and Operational Excellence across multiple platforms.

Responsibilities

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• Work with process 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; develop detailed specifications and engineering policies and procedures that affect multiple organizational units.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• Own and drive to completion Change Controls, CAPAs, and Deviations.
• 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 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.
• Handle Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automation systems, Preventive and Corrective Maintenance, System Administration, and Automation System spare parts management.
• Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
• 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: Degree requirements: High School Diploma / GED and 10 years of Engineering experience OR Associate’s Degree and 8 years of Engineering experience OR Bachelor’s Degree and 4 years of Engineering experience OR Master’s Degree and 2 years of Engineering experience OR Doctorate Degree.
• Preferred: Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Preferred: Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software.
• Preferred: Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• Preferred: Experience with Emerson DeltaV DCS system, Process Control Network design including network segregation, virtual infrastructure design and implementation, and ability to perform sophisticated troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies. Experience with DeltaV Live is preferred.
• 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: Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
• Preferred: Demonstrated 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.