Senior Automation Engineer Jobs in Raleigh, NC (NOW HIRING)

Amgen is building its newest and most advanced drug substance manufacturing plant – the FleX Batch facility. This plant will combine the latest disposable technologies with traditional stainless steel equipment to provide maximum flexibility, industry‑4.0 capabilities, and sustainability innovations that support Amgen’s goal of becoming carbon neutral by 2027.

The Senior Manufacturing Systems Engineer will provide automation technical leadership to a team of automation engineers responsible for building and maintaining automation systems that support GMP Drug Substance Plant operations.

The schedule for this position will be: 4 days × 10‑hour shift: Wednesday through Saturday.

In this vital role, you will work hand in hand with the Facilities & Engineering Automation team to deliver robust process automation systems for the new plant. This includes complex system automation initiatives that require solid understanding of automation platforms, integration among different platforms, analytical problem‑solving techniques, project management, lifecycle management, and operational excellence.

• 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, and 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 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, and large 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 24×7 onsite/on‑call support, troubleshooting for 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 time to look for new and innovative ways to do business differently, better, and more cost effectively.

• 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 a related field.
• Direct knowledge of automation system design and 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.
• 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 advanced troubleshooting activities using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies. Experience with DeltaV Live is 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, S 88, and S 95.
• 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.
• Demonstrated hands‑on experience in developing process control strategies for new product introduction and new technology deployment for drug substance plant operations.
• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times and reduced plant utilities usage).
• 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.
• Strong leadership, technical writing, and communication/presentation skills.

Amgen offers a total rewards plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

• Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program; for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
• Flexible work models, including remote work arrangements where possible.