Manufacturing Systems Engineer: Automation; Swing Shift

Manufacturing Systems Engineer:
Automation

As a Manufacturing Systems Engineer, you will work with a team of automation engineers to build, maintain, and support automation systems that enable GMP drug substance plant operations.

* The schedule for this position will be:
Swing Shift 3 pm - 11 pm:
Monday through Friday.

• Develop and maintain the process control system on Emerson Delta
  
  V distributed control system (DCS).
• Collaborate with key stakeholders and end‑users to understand and synthesize process requirements, and to 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 Amgen and industry standards.
• Support process automation systems to ensure design aligns with Amgen specifications, incorporates latest technology, and meets safety requirements.
• Support vendor FAT to ensure 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, and 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 feed your passion for groundbreaking technology, searching for innovative ways to do business more cost‑effectively.

What we expect from you

The automation professional we seek is an engineer with the following qualifications.

• High School Diploma / GED and 8 years of engineering experience OR
• Associate’s Degree and 6 years of engineering experience OR
• Bachelor’s Degree and 2 years of engineering experience OR
• Master’s 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 automation.
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Experience with Emerson Delta
  
  V DCS and 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 regulatory environment 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.

We support your professional and personal growth and well‑being through competitive benefits, flexible work models, and a collaborative culture.

In addition to the base salary, Amgen offers a Total Rewards Plan that may include:

• Comprehensive employee benefits package (Retirement and Savings Plan, medical, dental, vision, life and disability insurance, 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.

Equal Employment Opportunity

Amgen is an equal‑opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, disability, or any other protected status.