Senior Manufacturing Systems Engineer - PLC Systems

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Amgen seeks a Senior Manufacturing Systems Engineer (PLC) to lead automation projects for the FleX Batch facility in North Carolina. You will drive design, build, and qualification of PLC-based systems supporting drug substance production, with 24x7 operations responsibility.

You will work with capital projects, site engineering, and platform leads to ensure robust automation solutions, compliance with 21 CFR Part 11 and GMP, and effective process control across operations.

Qualifications

• High School Diploma/GED with 10+ years of engineering experience.
• Associates Degree with 8+ years of engineering experience.
• Bachelors Degree with 4+ years of engineering experience.
• Masters Degree with 2+ years of engineering experience.
• Doctorate Degree.

Responsibilities

• Lead site design, startup, and operational readiness for manufacturing.
• Develop PLC-based process control automation solutions with process engineering.
• Ensure network connectivity and system-to-system communication for centralized monitoring.
• Assist commissioning and qualification (IV/ACO) activities.
• Collaborate across units for readiness, reviews, deviations, and change control.
• Develop detailed specifications, SOPs, and operating standards impacting multiple units.
• Mentor and develop automation staff and capabilities.
• Provide 24x7 operational support and troubleshooting for systems.
• Lead capital projects and integrate new manufacturing technologies.
• Support new product introductions and technology introductions as needed.

Skills

PLC programming

Automation engineering

Team leadership

Technical writing

Project management

Education

HS Diploma/GED (10+ yrs eng)

Associate degree (8+ yrs eng)

Bachelor's degree (4+ yrs eng)

Master's degree (2+ yrs eng)

Doctorate degree

Tools

Rockwell platforms

Process control systems

Field instrumentation technologies

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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 not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

SeniorManufacturing Systems EngineerPLC

What Youwill Do

In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, and drive innovation and supportofPLC based processesand utility skid equipmentautomation needs.You will solve complex engineering problems and ensure the company's engineering efforts align with strategicobjectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations.

You will partner closely with the capital project team to design, build, commission, andqualifynew equipment and systems needed for drug substance production. This role will develop domainexpertiseto support operations upon start-up, focusing on manufacturing automation.

Job Responsibilities Include

Site design, construction, start-up, and operational readiness:

• Provide support to the capital project team with a strong focus on safety and on-time facility start-up.


• Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutionsforPLC basedsystems.


• Work withplatformleads to ensure standalone PLC based systems are designed withthe propernetwork connectivityandsystem-to-system communicationto enable centralized monitoring and alarming.


• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).


• Partner with various organizational units to support tasks including operational readiness, document reviews, deviationinvestigationand change controls.


• Develop andmaintaindetailed specifications,SOPsand operating standards thatimpactmultiple organizational units.


• Provide mentoring to develop and accelerate site technical automation capabilities.

Site Operations

• Act as system owner for standalone PLC based systems.


• Manage Day-to-day Operational Support including:24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations,preventive and corrective maintenance, system administration, andAutomation Systemspare parts management


• Lead and support functional area projects focused on improvingequipment/utilities/facilitiesas well as capital projects to integrate new drug substance manufacturing technologies into the facility.


• Lead and support technical root cause analysis, incident investigations, andtroubleshooting onprocess control issues related to plant operations.


• Lead and support new product introductions (NPI) ornew technologyintroductions by performingautomationengineering assessments, implementingautomationsystem configurationchangesand supporting engineering and process qualification runs as applicable.


• Prepare and review Standard Operating Procedures (SOP) and cGMP documents.


• On-site and up to 10%domestic/international travel

What We Expectofyou

We are all different, yet we all use our unique contributions to serve patients. The automation professional weseekis an engineer with these qualifications.

Basic Qualifications

• High School Diploma / GED and 10 years of Engineering experience OR


• Associates Degree and 8 years of Engineering experience OR


• Bachelors Degree and 4 years of Engineering experience OR


• Masters Degree and 2 years of Engineering experience OR


• Doctorate Degree

Preferred Qualifications

• Degree in Electrical Engineering or Computer Science, ChemicalEngineeringorBiotech Engineering.


• Extensive experience withprocess and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologiessuch as Rockwellplatforms.


• Direct knowledge of integrating various OEM automation software and field instrumentation technologies.


• Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.


• Experience in programming, design, installation and lifecycle management of PLC and field device/instrumentation technologies.


• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls,automationand field instrumentation technologies.


• In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.


• Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation.


• The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.


• Strong leadership, technical writing, and communication/presentation skills.

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.