Senior Manufacturing Systems Engineer: Automation - BAS / PLC

Join Amgen’s mission of serving patients. At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. Be part of Amgen's newest and most advanced drug substance manufacturing plant, the Amgen FleX batch facility, which combines disposable technologies with traditional stainless steel equipment for maximum flexibility. The FleX Batch facility will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and sustainability innovations to reduce carbon and waste, aligning with Amgen's plan to be a carbon-neutral company by 2027.

About the role

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 GMP Drug Substance Plant Operations. In this role, you will collaborate 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 process requirements and develop automation solutions using Amgen’s standard automation platform for building automation systems and process/utility skid equipment.
• Develop and maintain engineering and maintenance documentation, procedures, and support computerized systems validation processes in a GxP environment.
• Maintain Data Integrity Assessments with 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 commissioning and qualification plans for building automation systems and process/utility skid equipment.
• Ensure standalone PLC-based systems are designed with proper network connectivity for centralized monitoring and alarming.
• Support design phases to align equipment with Amgen’s specifications, incorporating the latest technology and meeting safety requirements.
• Lead vendor Factory Acceptance Testing (FAT) to ensure control strategy and software code meet Amgen’s requirements.
• Understand manufacturing operations to align control strategies with existing operations, facilitating equipment release and operation.
• Act as system owner for building automation systems and standalone PLC-based systems, responsible for system administration, maintenance procedures, spare parts, and engineering documentation.
• Own and drive Change Controls, CAPAs, and Deviations to ensure reliability and compliance.
• Lead and support functional area projects to improve process equipment, utilities, and facilities, integrating new drug substance manufacturing technologies.
• Drive continuous improvement for utility and building equipment systems to enhance operational workflows, safety, reliability, efficiency, and sustainability.
• Lead and support technical root cause analysis, incident investigations, and troubleshooting for utilities and building automation systems.
• Provide day-to-day operational support, including rotational on-call support for building automation systems and process/utility skid equipment.
• Perform and maintain data integrity assessments in accordance with Amgen Global Standard procedures.

Qualifications

Basic Qualifications:

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

Preferred Qualifications:

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related field.
• Direct knowledge of BMS design, building control engineering, and troubleshooting in GMP biopharmaceutical production facilities.
• Experience with building automation systems, process and utility skid equipment, and integrating OEM automation software and field instrumentation technologies.
• Knowledge 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 in a highly regulated environment (e.g., 21 CFR Part 11, ASTM 2500, S95).
• Self-directed team player with strong leadership, technical writing, and communication/presentation skills.
• Ability for domestic/international travel as needed.

Benefits

Amgen offers a Total Rewards Plan, based on eligibility, that includes:

• 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 sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements where possible.