Senior Manufacturing Systems Engineer: Automation - DeltaV

Senior Manufacturing Systems Engineer:
Automation - DeltaV

Apply for the “Senior Manufacturing Systems Engineer:
Automation - Delta

V” role n Amgen’s mission of serving patients through innovative biotechnology.

As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a team of engineers building and maintaining automation systems that support the GMP Drug Substance Plant Operations. You will work closely with the capital project team to deliver robust process automation systems for the new plant.

• Collaborate with key stakeholders and end-users to understand process requirements and develop solutions using Amgen’s standard automation platform.
• Support design phases to ensure alignment with Amgen specifications, incorporation of the latest technology, and 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.
• Collaborate with cross‑functional teams to develop a robust commissioning and qualification plan and/or qualification strategy.
• Support commissioning and qualification including Automation Installation Verification/Automation Check‑Out (IV/ACO).
• Support QA partners in performing computerized system validation in a GxP environment.
• Perform Data Integrity Assessments (DIA) in accordance with current Amgen and industry standards.

• Own and drive to completion change controls, CAPAs, and deviations.
• Lead and support technical root‑cause analysis, incident investigations, and troubleshooting.
• Lead and support functional area projects focused on improving process equipment, utilities, and facilities, and large capital projects integrating 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.
• Perform and maintain Data Integrity Assessments (DIA) in accordance with current Amgen and industry standards.

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

• High School diploma/GED and 10 years of engineering experience
• Associate’s degree and 8 years of engineering experience
• Bachelor’s degree and 4 years of engineering experience
• Master’s degree and 2 years of engineering experience
• Doctorate degree

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of automation system design.
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single‑use mixing vessels, depth filtration, and solution prep.
• Experience in integrating various OEM automation software.
• Experience in programming, design, installation, and lifecycle management of manufacturing process controls and automation and field instrumentation technologies.
• Experience with Emerson Delta
  
  V 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 leadership, technical writing, and communication skills.
• Ability for domestic and international travel.

From competitive benefits to a collaborative culture, we support your professional and personal growth. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards.

Apply today and make a lasting impact with the Amgen team!

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.