Manufacturing Systems Engineer: Automation Wednesday Shift

Manufacturing Systems Engineer:
Automation

You will work with a group of automation engineers responsible for building and maintaining automation systems and platforms that support the GMP Drug Substance Plant operations.

• 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 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.
• Support process automation systems to ensure design aligns with Amgen specifications, incorporates the 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 on 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 for groundbreaking technology, continually seeking innovative ways to do business better, safer, and more cost‑effective.

• 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

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of automation system design, process control engineering, and troubleshooting with GMP biopharmaceutical production facility equipment 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 integration of various OEM automation software.
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Experience in programming, design, installation, and lifecycle management of manufacturing process controls, 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, S 88 and S 95.
• 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 and a collaborative culture that supports your journey every step of the way.

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

• 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, or 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.