Manufacturing Systems Engineer: Automation

RiseMe; Holly Springs (NC); On-site; USD 105,000 - 143,000; Full time

Job summary

Amgen in North Carolina seeks a Manufacturing Systems Engineer focusing on automation for the new FleX Batch facility. You will work with automation engineers to build and sustain control systems that support GMP drug substance production.

The role involves collaborating with capital projects, documenting solutions, validating systems, and ensuring compliance with 21 CFR Part 11 and GMP standards. A strong background in DeltaV and process automation is essential.

Qualifications

• Bachelors degree with relevant engineering experience may be substituted by advanced degrees.
• Experience with GMP biopharmaceutical environments or similar regulated facilities is preferred.
• Strong documentation practices and ability to deliver clear procedures and records.

Responsibilities

• Develop and maintain the Emerson DeltaV DCS process control system.
• Collaborate with stakeholders to translate process requirements into automation solutions.
• Create and maintain engineering and maintenance documentation.
• Support computerized systems validation in a GxP environment.
• Conduct data integrity assessments per Amgen and industry standards.
• Drive continuous improvement for automation systems and safety.
• Perform change controls, CAPAs, and deviations to close.
• Support commissioning, qualification, and startup activities.

Skills

Automation engineering

Process control

GMP

Cross-functional teamwork

Technical writing

Education

Bachelor’s Degree with 2 years engineering experience

Master’s Degree

Associate’s Degree with 6 years engineering experience

High School Diploma / GED + 8 years engineering experience

Tools

Emerson DeltaV DCS

OPC

Foundation Fieldbus

Profibus

Job description

Career Category

Engineering

Job Description

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 have 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 will 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 lie within them, you will 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.

Manufacturing Systems Engineer: Automation

What you will do

Let's do this. Let's change the world. As a Manufacturing Systems Engineer, you will work with a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP DrugSubstancePlant 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.

Responsibilities:

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• 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.
• Provide clear documentation for delivered solutions and processes.
• 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.
• Support process automation systems 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.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• Site Operations
• Own and drive to completion Change Controls, CAPAs, and Deviations.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• 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.Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

What we expect from 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 8 years of Engineering experience OR
• Associate’s Degree and 6 years of Engineering experience OR
• Bachelor’s Degree and 2 years of Engineering experience OR
• Master’s Degree

Preferred Qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software.
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• 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 technical writing and communication skills.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for our teammates’ 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 a Total Rewards Plan based on eligibility that may include:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Salary Range

105,362.60USD -142,549.40USD

careers.amgen.com

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