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Senior Manufacturing Systems Engineer - PLC Systems

amgen

New
Senior 136,907 - 185,227 USD/year 🇬🇧 English
PLC Process control automation cGMP 21 CFR Part 11 GMP GAMP

Job description

About the role

Amgen is hiring a Senior Manufacturing Systems Engineer for its new FleX batch facility, which combines disposable technologies with traditional stainless steel equipment and includes Industry 4.0 and sustainability features. The role sits in the Facilities & Engineering group and leads technical projects, drives innovation and supports PLC-based processes and utility skid equipment automation, while guiding the Automation Engineering team supporting 24/7 manufacturing and facility operations.

Key responsibilities

  • Support the capital project team through site design, construction, start-up and operational readiness, with a focus on safety and on-time start-up.
  • Work with process engineering and platform leads to design PLC-based process control automation and network connectivity for centralized monitoring and alarming.
  • Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO).
  • Maintain specifications, SOPs and operating standards, and mentor site technical automation capabilities.
  • Act as system owner for standalone PLC systems, providing 24x7 onsite/on-call support, troubleshooting, preventive and corrective maintenance, spare parts management and system administration.
  • Lead root cause analysis, incident investigations and troubleshooting of process control issues, and support new product and technology introductions.
  • Review SOPs and cGMP documents, and prepare and review SOPs and cGMP documents.

Required profile

  • High school diploma / GED and 10 years of engineering experience, or Associate's degree and 8 years, or Bachelor's degree and 4 years, or Master's degree and 2 years, or Doctorate.
  • Preferred: degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering.
  • Self-directed team player ready to mentor engineers, with strong leadership, technical writing and communication skills.
  • Up to 10% domestic or international travel.

Required skills

  • Experience programming, designing, installing and managing PLCs and field devices, and integrating OEM automation software and field instrumentation (e.g., Rockwell platforms).
  • Knowledge of 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP and GMP.
  • Capital project lifecycle management, including design, implementation and validation.

What we offer

  • Salary range of $136,906.95 to $185,227.05.
  • Total rewards plans aligned with local industry standards.

Questions fréquentes

Le salaire proposé pour ce poste est de 137-185k USD par an. Le détail figure dans l'annonce.
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Source : ats:workday

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Published 1 day ago

Expires 1 month from now

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