Senior Manufacturing Systems Engineer: Automation - BAS / PLC

About the role

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this role as a member of the Facilities & Engineering (F&E) Automation team, you will work hand in hand with the capital project team to deliver robust building automation systems (BAS) and PLC-based process and utility skid equipment to operate the new plant.

Responsibilities

• Collaborate with key stakeholders to understand key process requirements and synthesize feedback from clients, customers, or end-users to develop the best automation solutions using Amgen standard automation platform for building automation systems and process and utility skid equipment.
• Develop and maintain engineering and maintenance documentation and associated procedures for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.
• Maintain Data Integrity Assessments with the current Amgen and industry standards.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy for the building automation systems and process and utility skid equipment in support of the project delivery.
• Work with platform leads to ensure standalone PLC-based systems are designed with the proper network connectivity to enable centralized monitoring and alarming.
• Support design phases to ensure equipment aligns with Amgen’s specifications, incorporates the latest technology, and meets safety requirements.
• Lead vendors FAT (for the automation testing) and ensure that control strategy and software code meet Amgen’s requirements. Emphasize understanding the benefits of a complete and successful FAT as a contributive factor to successful and on-time project delivery.
• Understand the manufacturing operation and ensure the control strategy aligns with existing manufacturing operations to facilitate release and operation of equipment, especially applicable for retrofit projects adding to an existing control system.
• Act as system owner for building automation system and standalone PLC-based systems responsible for System Administration, maintenance procedures and job plans, spare parts, and engineering documentation.
• Responsible for owning and driving to completion Change Controls, CAPAs, and Deviations as applicable to the assigned automation system to ensure reliability and compliance.
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
• Drive continuous improvement for utility and building equipment systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
• Lead/support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation systems.
• Provide day-to-day operational support including rotational on-call operational support for building automation systems and process and utility skid equipment.
• Perform and maintain data integrity assessments in accordance with the current Amgen Global Standard procedures and applicable standards.

Qualifications

Basic Qualifications

• High School Diploma / GED and 10 years of Engineering experience
• Associate’s Degree and 8 years of Engineering experience
• Bachelor’s Degree and 4 years of Engineering experience
• Master’s Degree and 2 years of Engineering experience
• Doctorate Degree

Preferred Qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of BMS design, experience in building control engineering, and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software.
• Experience with building automation systems and process and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologies.
• Knowledgeable of industry standards such as 21 CFR Part 11, ASTM 2500, S95, GAMP 5, and GDP.
• Experience in programming, design, installation, and lifecycle management of building automation controls, PLC, and field device/instrumentation 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, and S95.
• The ideal individual must be a self-directed team player able to work cross-functionally.
• Strong leadership, technical writing, and communication/presentation skills.
• Ability for domestic/international travel as needed.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.