Amgen Inc

Manufacturing Systems Engineer: Automation (Swing Shift Monday - Friday)

Amgen Inc • $105K — $142K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • High School Diploma/GED with 8 years of engineering experience, Associate's Degree with 6 years, Bachelor's Degree with 2 years, or a Master's Degree.
  • Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related field is preferred.
  • Direct experience with automation system design and troubleshooting in GMP biopharmaceutical production environments.
  • Familiarity with Emerson DeltaV DCS system, including advanced troubleshooting and integration capabilities.
  • Knowledge of GAMPs and GMPs, particularly the application of 21 CFR Part 11 and associated documentation standards.

Responsibilities

  • Develop and maintain process control systems using Emerson DeltaV DCS.
  • Collaborate with stakeholders to define process requirements and develop automation solutions.
  • Document delivered solutions and processes clearly and comprehensively.
  • Support QA in performing validation in a GxP context.
  • Conduct Data Integrity Assessments to ensure compliance with standards.
  • Assist in commissioning and qualification efforts in a fast-paced environment.
  • Drive continuous improvements for automation systems to enhance efficiency and safety.

Benefits

  • Comprehensive employee benefits package including medical, dental, and vision coverage.
  • Retirement and Savings Plan with generous company contributions.
  • Discretionary annual bonus program and long-term stock incentives.
  • Award-winning time-off plans and bi-annual company-wide shutdowns.
  • Flexible work models, including potential remote work arrangements.
Full Job Description
Career Category
Engineering
Job Description

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 Drug Substance Plant Operations.

*The schedule for this position will be: Swing Shift 3pm - 11pm: Monday through Friday.*

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 robustprocess 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 -142,549.40 USD

About Amgen Inc

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. The company is values-based and deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious diseases. They offer products for treating illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.

Amgen Inc Careers

Join the dynamic team at Amgen Inc, a biotechnology pioneer dedicated to discovering, developing, and delivering innovative human therapeutics. At Amgen, we offer more than just job opportunities; we invite you to be part of a culture of leadership, diversity, and innovation.

Work You’ll Do

At Amgen Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that brings real solutions to patients worldwide. Our commitment to your career growth is evident in our professional development and leadership training programs designed to nurture your potential.

Innovate and Lead

Amgen Inc stands at the forefront of biotech innovation. Our team is constantly pushing the boundaries of science and technology. By joining us, you will contribute to a legacy of medical breakthroughs that improve the lives of millions.

Be Part of a Great Team

Amgen’s inclusive culture and commitment to diversity are integral to our success. We believe in empowering our employees with the skills and networking opportunities they need to thrive. Our team’s collaboration is the key to developing groundbreaking solutions.

Future-Proof Your Career

Amgen Inc offers a variety of career paths, from research and development to marketing and sales, providing near-limitless opportunities for advancement. Whether you are looking for a full-time position, an internship, or a leadership role, Amgen has a place for you. Our robust benefits package supports the well-being of our employees and their families, contributing to a fulfilling work-life balance.

Explore Job Opportunities

Discover the impact you can make with a career at Amgen Inc. We are hiring creative, curious, and motivated individuals ready to face challenges head-on. Explore our open positions that match your skills and interests.

Stay Connected

Join our team and stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await.

Interview and Resume Tips

Prepare for your future with Amgen Inc by utilizing our resources designed to enhance your interview skills and polish your resume. Our hiring process is designed to identify and attract professionals who are driven to make a difference.

Amgen Inc—Where Careers Grow

At Amgen Inc, we are committed to turning innovative science into value for patients. If you are passionate about joining a team that makes a difference, search Amgen jobs today and take the first step towards a fulfilling career.

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Join us at Amgen Inc, where your career can flourish in an environment of innovation, leadership, and growth.
Learn more about Amgen Inc
Size
24,200 employees
Market Cap
$141.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7.2 billion
Founded
1980
5 Year Trend
+2.5%
Revenue
$25.4 billion
NASDAQ
AMGN
* Ladders Estimates

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