Manufacturing Systems Engineer: BAS/QBAS

About This Role

As a Manufacturing Systems Engineer specializing in BAS/QBAS, you will be part of the Facilities & Engineering (F&E) Automation team, responsible for building and maintaining automation systems supporting GMP Drug Substance Plant Operations at Amgen's new FleX batch facility. This role involves delivering robust automation solutions, supporting commissioning and qualification efforts, and assisting with day-to-day operational support.

Responsibilities

• Maintain the Building Automation System (BAS/QBAS) on Siemens Desigo CC
• Work with process subject matter experts (SMEs) to transform key process requirements into digital automated solutions
• Collaborate with business partners to improve workflow and productivity through utility and building equipment systems automation
• Provide clear documentation for delivered solutions and processes, supporting computerized systems validation in a GxP environment
• Maintain detailed specification and engineering policies and procedures
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO)
• Support functional area projects focused on improving process equipment/utilities/facilities and complex capital projects
• Support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation controls
• Support new product introductions (NPI) or new technology introductions by performing automation engineering assessments
• Assist with Day-to-Day Operational Support, including 24x7 Onsite/On Call, troubleshooting, administration, and maintenance

Requirements

• Experience with Building Automation System (BAS/QBAS)
• High School Diploma / GED and 8 years of Engineering experience OR Associates Degree and 6 years of Engineering experience OR Bachelors Degree and 2 years of Engineering experience OR Masters Degree

Qualifications

• High School Diploma / GED and 8 years of Engineering experience OR Associates Degree and 6 years of Engineering experience OR Bachelors Degree and 2 years of Engineering experience OR Masters Degree
• 2+ years of Engineering experience with a Bachelor's Degree, or more with lower levels of education

Nice to Have

• Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering
• Direct knowledge of BAS design, building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation
• Extensive understanding and background in programming, design, installation and lifecycle management of building automation controls, PLC, and field device/instrumentation technologies
• Experience with Siemens Building Automation Desigo CC system, Rockwell industrial automation hardware and systems
• Ability to perform sophisticated troubleshooting activities with Amgen DTI
• Experience with System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project implementation
• Experience with continuous improvements resulting in enhanced safety, system reliability, and productivity
• Self-directed team player with strong technical writing and communication/presentation skills

Skills

* Required skills

Benefits