Sr. Systems Engineer - Project Delivery Lead

Amgen; Puerto Rico; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Total Rewards Plan

Job summary

Amgen seeks a Sr. Systems Engineer - Project Delivery Lead to drive the digital transformation of manufacturing systems across complex facilities.

You will lead MES/SCADA integrations and Industry 4.0 initiatives, developing budget estimates and coordinating cross-functional teams to define system requirements and validation plans. Responsibilities include ensuring cGMP compliance, data integrity, cybersecurity, training users, supporting commissioning and qualification, and staying ahead of

Qualifications

• PhD in Engineering required for the role.
• Advanced degree with relevant manufacturing systems/automation experience.
• Strong background in validated, regulated biopharma processes.

Responsibilities

• Lead the digital transformation of manufacturing systems across facilities.
• Define system requirements and ensure alignment with business needs.
• Develop budgetary cost estimates for technology scope of capital projects.
• Ensure cGMP compliance, data integrity, and cybersecurity.

Education

Doctorate degree in Engineering

Master's degree in Engineering and 2 years of Manufacturing Systems/Automation experience

Bachelor's degree in Engineering and 4 years of Manufacturing Systems/Automation experience

Tools

Rockwell software platform

Machine Vision (Cognex)

Systech Serialization (Guardian/Advisor/Sentri)

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've helped pioneer the world of biotech in our fight against the world's toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Sr. Systems Engineer - Project Delivery Lead

What you will do

Let's do this. Let's change the world. In this vital role you will lead the digital transformation of manufacturing systems, driving innovation, compliance, and operational excellence through ground breaking automation and smart technologies.

Serve as a subject matter expert in manufacturing systems and digital technologies.

Lead the implementation and integration of MES, SCADA, Industry 4.0 solutions, and other manufacturing IT systems.

Lead the development of budgetary cost estimates for the technology scope of capital projects

Collaborate with multi-functional teams to define system requirements and ensure alignment with business needs.

Develop system documentation, including user requirements, design specifications, and test plans.

Troubleshoot system issues and coordinate resolution with IT and vendor support teams.

Ensure system compliance with cGMP, data integrity, and cybersecurity requirements.

Support system commissioning & qualification, validation and change control activities.

Train users on system functionality and best practices.

Participate in audits and inspections, providing system documentation and support.

Stay informed on new technologies and digital trends in manufacturing.

Promote a culture of digital innovation and operational excellence.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Associate Mfg Systems Engineer professional we seek is a technical individual contributor with these qualifications

Basic Qualifications:

• Doctorate degree in Engineering
• Master's degree in Engineering and 2 years of Manufacturing Systems/Automation experience
• Bachelor's degree in Engineering and 4 years of Manufacturing Systems/Automation experience

Preferred Qualifications:

• Advance degree in Computer, Electrical, Mechanical, Chemical Engineering, or Biomedical Engineering
• Knowledge and/or experience of pharmaceutical/biotech processes, especially in the areas of inspection or packaging operations
• Organizational, project management, and problem-solving capability
• Knowledge in Data Integrity and Cybersecurity
• Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies
• Expertise in Databases
• Expertise in Rockwell software platform
• Expertise in Machine Vision (Cognex), preferred
• Direct experience with Systech Serialization projects including experience with Guardian, Advisor, Sentri, and other Systech ancillary devices.
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment
• Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
• Excellent verbal and written communication skills together with demonstrated ability to work in a team environment.
• -Proven track record of leading and executing cross-functional projects.
• -Strong teamwork, excellent interpersonal and communication skills.
• -Direct experience with medical devices/combination products and associated manufacturing processes.
• Experience in working with third-party vendors and equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• -Ability to learn and rapidly adapt to new requirements in a fast-moving environment.
• An Operational Excellence and Lean Transformation approach to work product - driving rapid results.

What you can expect of 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.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirem