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.

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• 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; develop detailed specification 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 completion of 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.
• Manage day‑to‑day operational support including 24x7 onsite/on‑call operational support, troubleshooting support to plant and manufacturing 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.

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.

• 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 automations 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.
• 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…