Senior Manufacturing Systems Engineer:Automation- DeltaV Saturday Shift

Senior Manufacturing Systems Engineer:
Automation
- DeltaV

Schedule:

4 days x 10 hour shift, Wednesday through Saturday.

As a senior manufacturing systems engineer, you will provide automation technical leadership to a group of automation engineers responsible for building and maintaining automation systems and platforms that support GMP Drug Substance Plant Operations. You will work with the capital project team to deliver robust process automation systems for the new plant, handling complex initiatives across multiple automation platforms, integration, analytics, project management, lifecycle management, and operational excellence.

• 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 identify how automation can improve workflow and productivity; synthesize requirements from clients, customers, and 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 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.
• On‑going operations:
  • Own and drive to completion of change controls, CAPAs, and deviations.
  • 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 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.
  • Manage day‑to‑day operational support including 24x7 onsite/on‑call support, troubleshooting, preventive and corrective maintenance, system administration, and spare parts management for automation systems.
  • Prepare/review standard operating procedures (SOP) and cGMP documents.
• Be constantly curious and pursue innovative ways to improve business, technology, and cost‑efficiency.

• 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.

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of automation system design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automationsuch 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.
• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• Experience with Emerson DeltaV DCS system, process control network design including network segregation, virtual infrastructure design and implementation, and ability to perform advanced troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and Device Net technologies. Experience with DeltaV…