Manufacturing Systems Engineer: Automation - DeltaV (Swing Shift Monday - Friday)

NCBiotech; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Discretionary annual bonus program

Flexible work models

Job summary

Amgen SA in Holly Springs is seeking a Manufacturing Systems Engineer. In this role, you will develop and maintain automation systems that support GMP Drug Substance Plant Operations, ensuring compliance with industry standards while driving continuous improvements in operational workflows. This position requires experience in engineering, particularly in automation system design.

The ideal candidate will have a background in Electrical Engineering or related fields, a passion for technology, and the ability to work cross-functionally in a regulated environment. Amgen offers a comprehensive benefits package, including medical, dental, vision coverage, and flexible work models.

Qualifications

• Bachelor's Degree with 2 years of Engineering experience is preferred.
• Direct experience with GMP biopharmaceutical production equipment.
• Experience with automation and field instrumentation technologies.

Responsibilities

• Develop and maintain process control systems on Emerson DeltaV.
• Collaborate with stakeholders to develop automation solutions.
• Support QA with computerized systems validation.

Skills

Automation System design

Process control engineering

Technical writing

Communication skills

Troubleshooting

Education

Bachelor's Degree in Engineering or related field

High School Diploma / GED with 8 years of experience

Associate Degree with 6 years of experience

Master's Degree

Tools

Emerson DeltaV DCS system

Job description

Manufacturing Systems Engineer: Automation - DeltaV

As a Manufacturing Systems Engineer, you will work with a group of automation engineers responsible for building and maintaining automation systems that support GMP Drug Substance Plant Operations.

Schedule

Swing Shift 3pm - 11pm, Monday - Friday.

Responsibilities

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• Collaborate with key stakeholders and end‑users to understand and synthesize key process requirements, and develop solutions using Amgen's standard automation platform for process automation systems.
• Provide clear documentation for delivered solutions and processes.
• Support QA partners in performing computerized systems validation in a GxP environment.
• Perform Data Integrity Assessments (DIA) in accordance with current Amgen and industry standards.
• Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements.
• Support vendor FAT to ensure that control strategy and software code meet Amgen requirements.
• Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes.
• 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.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• Support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility.
• Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
• Support day‑to‑day operations including rotational on‑call support.
• 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.

Basic Qualifications

• High School Diploma / GED and 8 years of Engineering experience.
• Associate’s Degree and 6 years of Engineering experience.
• Bachelor’s Degree and 2 years of Engineering experience.
• Master’s Degree.

Preferred Qualifications

• 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 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.
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting and system integration using OPC, Foundation Fieldbus, and Profibus technologies.
• 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.
• Self‑directed team player able to work cross‑functionally.
• Strong technical writing and communication skills.

Benefits

• 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.
• Discretionary annual bonus program.
• 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.