Senior Manufacturing Systems Engineer - Building Automation Systems (BAS)

About the role

Amgen is hiring a Senior 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 lead automation engineers in delivering building automation systems (BAS) and PLC-based process and utility skid equipment for the new plant, working with the Facilities & Engineering (F&E) Automation team and the capital project team.

Key responsibilities

• Support site design, construction, start-up and operational readiness: gather stakeholder and user feedback and develop automation solutions using Amgen's standard automation platform.
• Maintain engineering and maintenance documentation and procedures, support computerized systems validation in a GxP environment, and maintain Data Integrity Assessments.
• Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO), and build the commissioning and qualification plan with cross-functional teams.
• Work with platform leads so standalone PLC systems have the right network connectivity for centralized monitoring and alarming, and ensure equipment meets Amgen specifications, safety requirements and the latest technology.
• Lead vendor FATs, check that control strategies and software code meet Amgen requirements, and ensure control strategies fit existing manufacturing operations, especially for retrofits.
• Act as system owner for BAS and standalone PLC systems: administration, maintenance procedures, job plans, spare parts and documentation.
• Own and drive Change Controls, CAPAs and deviations, lead functional area and capital projects, and drive continuous improvement for utilities and building systems.
• Lead root cause analysis, incident investigations and troubleshooting, and provide rotational on-call operational support.

Required profile

• Basic: 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 engineering, computer science, chemical engineering, biotech engineering or a related field.
• Self-directed team player able to work cross-functionally, with strong leadership, technical writing and communication skills.
• Ability to travel domestically and internationally as needed.

Required skills

• Knowledge of BMS design, building control engineering and troubleshooting in GMP biopharmaceutical facilities.
• Experience with building automation systems, process and utility skid equipment, and integrating OEM automation software and field instrumentation.
• Programming, design, installation and lifecycle management of building automation controls, PLCs and field devices.
• Familiarity with 21 CFR Part 11, ASTM 2500, S95, GAMP 5 and GDP, and ability to interpret GAMPs and GMPs.