Senior Manufacturing Systems Engineer: Automation

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. 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 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, you’ll 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, you’ll 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.

Senior Manufacturing Systems Engineer: Automation

What you will do

Let’s do this. Let’s change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.

In this vital 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 process automation systems to operate the new plant.

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

• Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
• Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
• Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
• Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
• Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
• Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
• Support QA partners in performing computerized systems validation in a GxP environment
• Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards

Site Operations

• Own and drive to completion Change Controls, CAPAs, and Deviations
• Lead and support technical root cause analysis, incident investigations, and troubleshooting
• Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
• Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
• Support day-to-day operations including rotational on-call support
• Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these 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 related field
• Direct knowledge of automation system design
• Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
• Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
• Experience in integrating various OEM automation software
• Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.
• Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus 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
• Self-directed team player able to work cross-functionally
• Strong leadership, technical writing, and communication skills
• Ability for domestic and international travel

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, we’ll 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.

Apply now and make a lasting impact with the Amgen team!

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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.