Manufacturing Systems Engineer - Automation (DeltaV)

About the role

Amgen is hiring a Manufacturing Systems Engineer for its new FleX Batch drug substance manufacturing plant, working within the Facilities & Engineering Automation team. You will build and maintain automation systems and platforms supporting GMP plant operations, alongside the capital project team, on a swing shift from 3pm to 11pm, Monday through Friday.

Key responsibilities

• Develop and maintain the process control system on the Emerson DeltaV distributed control system (DCS)
• Work with stakeholders and end-users to define process requirements and build solutions using Amgen's standard automation platform, with clear documentation
• Support QA partners in computerized systems validation in a GxP environment and perform Data Integrity Assessments
• Support vendor FAT and commissioning, including Automation IV/ACO
• Own Change Controls, CAPAs and deviations, and support root cause analysis and troubleshooting
• Support projects improving equipment, utilities and facilities, and prepare/review SOPs and cGMP documents
• Drive continuous improvement of automation systems and provide rotational on-call support

Required profile

• High school diploma / GED and 8 years of engineering experience, or Associate's degree and 6 years, or Bachelor's degree and 2 years, or Master's degree
• Preferred: degree in Electrical, Computer, Chemical or Biotech Engineering
• Ability to interpret and apply GAMPs and GMPs, and familiarity with 21 CFR Part 11, ASTM 2500, S88 and S95
• Strong technical writing and communication skills, self-directed team player

Required skills

• Emerson DeltaV DCS and advanced troubleshooting
• Process control engineering and automation programming, installation and lifecycle management
• System integration using OPC, Foundation Fieldbus and Profibus

What we offer

• Salary range of $105,362.60 to $142,549.40
• Benefits package including retirement and savings plan, medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Time-off plans, flexible work models including remote work where possible