Senior Manufacturing Systems Engineer

About the role

Amgen is hiring a Senior Manufacturing Systems Engineer for its drug substance manufacturing plant, which is expanding and adding Industry 4.0 technologies. The engineer works with process subject matter experts and business partners to turn process requirements into digital automated solutions, and leads projects that integrate new manufacturing technologies.

Key responsibilities

• Turn process requirements into digital automated solutions and collaborate with clients, customers and end users on automation improvements.
• Lead and support projects improving process equipment, utilities and facilities, and large capital projects introducing new manufacturing technologies.
• Support new product and new technology introductions through automation engineering assessments, configuration changes and engineering and process qualification runs.
• Build business processes aligned with project timelines and write detailed specifications, engineering policies and procedures.
• Document delivered solutions and support computerized systems validation in a GxP environment with QA partners.
• Resolve project issues and manage multiple initiatives, and stay curious about new ways to do business.

Required profile

• Basic qualifications: doctorate, or master's degree with 2 years of manufacturing process automation/information system experience, or bachelor's degree with 4 years, or associate's degree with 8 years, or high school diploma with 10 years of the same experience.
• Preferred: demonstrable manufacturing experience in pharmaceutical or biotechnology, and a self-directed team player ready to mentor engineering staff.
• Strong leadership, technical writing and communication skills.

Required skills

• Preferred: automation design, process control engineering and troubleshooting of GMP biopharmaceutical equipment (media, harvest, bioreactors, chromatography, vial filtration, ultrafiltration/diafiltration).
• Preferred: programming, design, installation and lifecycle management of process controls, automation and field instrumentation.
• Preferred: Emerson Delta-V DCS, Process Control Network design, and GAMP, ANSI/ISA-S88 and S95 standards.
• Preferred: capital project lifecycle management and hands-on process control strategy development for NPI.
• Preferred: hands-on coding of Emerson Delta V, Rockwell FactoryTalk and Rockwell PLCs; Aveva PI Data Historian and Kneat C&Q documentation knowledge are a plus.

What we offer

• Annual salary range posted, with a discretionary bonus or sales-based incentive depending on role.
• Health, dental and vision coverage, life and disability insurance, retirement savings plan and flexible spending accounts.
• Stock-based long-term incentives and time-off plans.
• Flexible work models, including remote and hybrid options where possible.