Manufacturing Systems Engineer: Automation - DeltaV; Swing Shift

Manufacturing Systems Engineer:
Automation - DeltaV

As a Manufacturing Systems Engineer, you will work with a group of automation engineers who build and maintain automation systems and platforms that support GMP Drug Substance Plant Operations. The schedule for this position is Swing Shift 3pm – 11pm, Monday through Friday. You will collaborate with the capital project team to deliver robust process automation systems to operate the new plant.

• 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.
• 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.
• Ensure process automation systems meet Amgen specifications, incorporate latest technology, and satisfy safety requirements.
• Support vendor Factory Acceptance Testing (FAT) to confirm 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.
• 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 look for new and innovative ways to improve business processes.

• 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)
• Preferred Qualifications
• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
• Direct knowledge of automation system design, process control engineering, and troubleshooting in GMP biopharmaceutical production facilities
• Experience designing, installing, and managing automation and field instrumentation technologies
• Experience with Emerson DeltaV DCS and advanced troubleshooting, system integration using OPC, Foundation Fieldbus, and Profibus
• Ability to interpret and apply GAMP, GMP, 21 CFR Part 11, ASTM 2500, S88, and S95 documentation requirements
• Self‑directed team player with strong technical writing and communication skills

• Competitive base salary and total rewards plan, including discretionary annual bonus and stock‑based incentives
• Comprehensive employee benefits package: retirement and savings plan with company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
• Award‑winning time‑off plans and bi‑annual company shutdowns
• Flexible work models, including remote work arrangements where possible

Amgen is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or any other protected status under applicable law.