Manufacturing Systems Engineer: Automation

About the role

Amgen is hiring a Manufacturing Systems Engineer for its new drug substance manufacturing plant, the FleX Batch facility, which combines disposable technologies with stainless steel equipment and includes Industry 4.0 and sustainability features. You will join the Facilities & Engineering (F&E) Automation team and work with automation engineers to build and maintain automation systems supporting GMP drug substance plant operations, working closely with the capital project team.

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 (DIA)
• Ensure automation designs meet Amgen specifications, incorporate the latest technology and meet safety requirements
• Support vendor FAT so that control strategy and software code meet Amgen requirements
• Maintain engineering and maintenance documentation and procedures
• Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO)
• Own and drive Change Controls, CAPAs and deviations, and support root cause analysis and troubleshooting
• Support projects improving process equipment, utilities and facilities, and drive continuous improvement
• Support day-to-day operations with rotational on-call support, and prepare and review SOPs and cGMP documents

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 Engineering, Computer Science, Chemical Engineering, Biotech Engineering or a related field
• Self-directed team player able to work cross-functionally, with strong technical writing and communication skills

Required skills

• Emerson DeltaV DCS and advanced troubleshooting and system integration with OPC, Foundation Fieldbus and Profibus
• Knowledge of automation system design, process control engineering and GMP biopharmaceutical equipment (media, harvest, bioreactors, single-use mixing, chromatography, TFF, viral filtration, UF/DF, drug substance fill, CIP/SIP, clean utilities)
• Programming, installation and lifecycle management of automation and field instrumentation
• Ability to interpret and apply GAMPs and GMPs, and familiarity with 21 CFR Part 11, ASTM 2500, S88 and S95

What we offer

• Base salary of $105,362.60 to $142,549.40, plus a Total Rewards Plan
• Retirement and savings plan with company contributions, 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
• Award-winning time-off plans, bi-annual company-wide shutdowns, and flexible work models including remote work where possible