Senior Manufacturing Systems Engineer - Holly Springs, NC

Senior Manufacturing Systems Engineer – DeltaV

In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, and drive innovation and support manufacturing's upstream, downstream, and solution preparation automation needs. You will solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations.

You will partner closely with the capital project team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise to support operations upon start-up, focusing on manufacturing automation.

Job responsibilities include:

• Site design, construction, start-up, and operational readiness:
• Provide support to the capital project team with a strong focus on safety and on-time facility start-up.
• Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS) for upstream, downstream, and/or solution prep operations.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
• Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls.
• Develop and maintain detailed specifications, SOPs and operating standards that impact multiple organizational units.
• Provide mentoring to develop and accelerate site technical automation capabilities.
• Site Operations:
• Act as system owner for Upstream, Downstream, and/or Solution prep Automation processes.
• Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automaton systems, and Automation System spare parts management
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as 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.
• Prepare and review Standard Operating Procedures (SOP) and cGMP documents.
• On-site role and up to 10% domestic/international travel