Senior Manufacturing Systems Engineer - Automation (DeltaV)

About the role

Amgen is hiring a Senior Manufacturing Systems Engineer for its Facilities & Engineering Automation team, working on the new FleX batch facility for drug substance manufacturing. You will lead a group of automation engineers building and maintaining automation systems that support GMP plant operations, working with the capital project team to deliver robust process automation. The schedule is swing shift, 3pm to 11pm, Monday through Friday.

Key responsibilities

• Develop and maintain the process control system on the Emerson DeltaV distributed control system (DCS)
• Translate process requirements from SMEs and customers into digital automation solutions, with clear documentation and support of computerized systems validation in a GxP environment
• Maintain Data Integrity Assessments and build business processes aligned with project timelines
• Develop specification and engineering policies and procedures
• Support commissioning and qualification, including Automation IV/ACO, and own Change Controls, CAPAs and deviations
• Lead root cause analysis, incident investigations and troubleshooting of process control issues
• Support NPI and new technology introductions, including automation engineering assessments and qualification runs
• Manage day-to-day operational support: 24x7 onsite/on-call support, troubleshooting, preventive and corrective maintenance, system administration and spare parts management
• Review SOPs and cGMP documents, and lead capital projects and continuous improvement initiatives

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 of engineering experience
• Preferred: degree in Electrical, Computer, Chemical, Biotech Engineering or a related field
• Self-directed team player able to mentor engineering staff, with strong leadership, technical writing and presentation skills

Required skills

• Emerson DeltaV DCS and DeltaV Live (preferred)
• Process control engineering, troubleshooting and lifecycle management of automation and field instrumentation
• Programming, design, installation and integration of automation systems
• Knowledge of GAMPs, GMPs, 21 CFR Part 11, ASTM 2500, S88 and S95
• Capital project lifecycle management and process control strategy for drug substance plants

What we offer

• Total rewards plan with health, dental and vision coverage, life and disability insurance, and a retirement and savings plan with company contributions
• Discretionary annual bonus program
• Career development opportunities