Job highlights
Identified by Google from the original job post
Qualifications
(e.g. AR/VR Technology, MES, ERP, Finite Scheduling-VIRTEC, Workforce modeling, Instrumentation Integration, Artificial Intelligence (AI)/Machine Learning, etc.)
Recognize and demonstrate understanding of interdependencies between key business systems, smart technologies and the manufacturing business process to assess impact to the organization
High school diploma / GED and 10 years of Manufacturing, Engineering, Business Analysis or Computer Science experience OR
Associate degree and 8 years of Manufacturing, Engineering, Business Analysis or Computer Science experience OR
Bachelor’s degree and 4 years of Manufacturing, Engineering, Business Analysis or Computer Science experience OR
Master’s degree and 2 years of Manufacturing, Engineering, Business Analysis or Computer Science experience OR
Doctorate degree
Benefits
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Responsibilities
In this vital role you will be part of a dynamic team that leads various smart manufacturing technologies and computerized system improvement initiatives within manufacturing to support the end user on the shop floor as well as support the business with data analytics and reporting
You will own critical processes, provide technical leadership, and be accountable for design, implementation, validation and lifecycle management of systems and digital technologies
This role is critical for Amgen North Carolina’s success and key in supporting operations towards a more digital future
Act as manufacturing business owner and SME for key digital technologies (e.g
Digital Control Tower (DCT), Augmented Reality, Virtual Reality, Finite Scheduling) and ensure timely implementation of projects including software or system lifecycle management
Provide technical support and subject matter expertise in all digital topics related to the manufacturing area
Demonstrate broad technical knowledge on various smart technologies and business systems used in the network
Supporting the site in project approvals, project management, prioritization and leading all aspects of the roll-out and implementation of manufacturing technology concepts for the manufacturing area
Collaborate with Continuous Improvement (CI) leads to help digitally track and visualize site CI projects and provide/lead use cases for potential digital continuous improvement projects
Develop materials and coordinate/schedule training sessions for delivering training of new and existing manufacturing personnel on topics related to manufacturing technologies
Apply independent input and judgment to trouble shoot key computerized systems and digital technologies during problem solving to drive process efficiencies
Apply analytical skills to evaluate and interpret complex scenarios and provide insight in manufacturing performance metrics (e.g. key performance indicator tools, SQL, Data Architecture skills, Tableau, Data Analytics and Visualization tools) using qualitative research and data
Collaborate with cross functional teams to develop new processes and drive continuous improvements to unlock capacity and increase efficiency within the manufacturing area
Supporting system and document lifecycle management for key computerized systems and business processes and represent the team during project meetings
Generate, and review documents (SOPs, FORMs, Deviations, CAPA, CC, validation protocols, etc.) associated with and owned by the digital manufacturing team
Understand operational needs and develop novel yet practical data-driven solutions to meet those needs
Build business cases to secure funding for projects and implementation of additional digital technologies
Partner with other facilities in the network as well as global digital teams to ensure implementation of digital standard methodologies and continuous improvement
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’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 single use 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 Digital Specialist

What You Will Do

Let’s do this. Let’s change the world. In this vital role you will be part of a dynamic team that leads various smart manufacturing technologies and computerized system improvement initiatives within manufacturing to support the end user on the shop floor as well as support the business with data analytics and reporting. You will own critical processes, provide technical leadership, and be accountable for design, implementation, validation and lifecycle management of systems and digital technologies. This role is critical for Amgen North Carolina’s success and key in supporting operations towards a more digital future.

Key Responsibilities Include
• Act as manufacturing business owner and SME for key digital technologies (e.g. Digital Control Tower (DCT), Augmented Reality, Virtual Reality, Finite Scheduling) and ensure timely implementation of projects including software or system lifecycle management.
• Provide technical support and subject matter expertise in all digital topics related to the manufacturing area.
• Demonstrate broad technical knowledge on various smart technologies and business systems used in the network. (e.g. AR/VR Technology, MES, ERP, Finite Scheduling-VIRTEC, Workforce modeling, Instrumentation Integration, Artificial Intelligence (AI)/Machine Learning, etc.).
• Recognize and demonstrate understanding of interdependencies between key business systems, smart technologies and the manufacturing business process to assess impact to the organization.
• Supporting the site in project approvals, project management, prioritization and leading all aspects of the roll-out and implementation of manufacturing technology concepts for the manufacturing area.
• Collaborate with Continuous Improvement (CI) leads to help digitally track and visualize site CI projects and provide/lead use cases for potential digital continuous improvement projects.
• Develop materials and coordinate/schedule training sessions for delivering training of new and existing manufacturing personnel on topics related to manufacturing technologies.
• Apply independent input and judgment to trouble shoot key computerized systems and digital technologies during problem solving to drive process efficiencies.
• Apply analytical skills to evaluate and interpret complex scenarios and provide insight in manufacturing performance metrics (e.g. key performance indicator tools, SQL, Data Architecture skills, Tableau, Data Analytics and Visualization tools) using qualitative research and data.
• Collaborate with cross functional teams to develop new processes and drive continuous improvements to unlock capacity and increase efficiency within the manufacturing area.
• Supporting system and document lifecycle management for key computerized systems and business processes and represent the team during project meetings.
• Generate, and review documents (SOPs, FORMs, Deviations, CAPA, CC, validation protocols, etc.) associated with and owned by the digital manufacturing team.
• Understand operational needs and develop novel yet practical data-driven solutions to meet those needs.
• Build business cases to secure funding for projects and implementation of additional digital technologies.
• Partner with other facilities in the network as well as global digital teams to ensure implementation of digital standard methodologies and continuous improvement.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The We are looking for a collaborative partner with an understanding of manufacturing operations and a passion for digital manufacturing and data analytics, with the following qualifications:

Basic Qualifications
• High school diploma / GED and 10 years of Manufacturing, Engineering, Business Analysis or Computer Science experience OR
• Associate degree and 8 years of Manufacturing, Engineering, Business Analysis or Computer Science experience OR
• Bachelor’s degree and 4 years of Manufacturing, Engineering, Business Analysis or Computer Science experience OR
• Master’s degree and 2 years of Manufacturing, Engineering, Business Analysis or Computer Science experience OR
• Doctorate degree

Preferred Qualifications
• Hands-on experience with some of the key digital technologies and data analytics systems (MES, ERP, Smartsheets, Data Visualization) and/or digital manufacturing technologies (AR/VR Technologies, Tableau, AI) including troubleshooting, reliability, and performance improvements.
• Experience in participating and helping lead multi-functional teams toward implementation of digital technologies.
• Experience with communicating data and metrics to leaders and developing strong relationships with teams to advance digital ideas and tools.
• Demonstrate comprehensive understanding of the Manufacturing process with the ability to translate to critical business requirements to enable design of computerized systems for the end user.
• Expertise with translating business/user needs to user requirements and recommend solutions for automation.
• Data/process performance analysis and reporting experience by using analytics, visualization, and database technologies (critical metrics, Tableau)
• Experience with design, configuration, qualification/validation in digital manufacturing and computerized systems and system integration supporting manufacturing and the end user (e.g. MES, ERP, SCADA).
• Analytical fact-based problem solver and strong troubleshooting skills on process, equipment, technology, and computerized systems.
• Experience in individually supporting key manufacturing systems with 24x7 operations.
• Ability to maintain an environment of operation excellence, continuous improvement, and lean manufacturing (Kaizen process improvements).
• The ability/experience of working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able to adapt quickly to the demands of commercial manufacturing operations.
• Experience in a GMP environment and able to work within full GMP compliance.
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality.
• Pro-active, result oriented, and ability to prioritize work to meet timelines.

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!

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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, ****** 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.