Principal Manufacturing Systems Engineer - Amgen North Carolina Site Lead

HOW MIGHT YOU DEFY IMAGINATION?

Ensure all your application information is up to date and in order before applying for this opportunity.

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission to serve patients drives all that we do.

It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.

It’s time for a career you can be proud of.

Principal Manufacturing Systems Engineer - Amgen North Carolina Site Lead

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of Amgen's most technologically advanced drug substance manufacturing plant.

The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide.

As a Principal Manufacturing Systems Engineer you will :

• Own the successful delivery of varied portfolio of IS / Automation projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by using technical, project management, and business expertise.
• Perform cross system assessments, feasibility analysis, scope projects, prioritize work you're doing, and recommend optimal solution.

Manage multiple initiatives and priorities.

• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements.
• Effectively manage relationships with Peers, IS service owners, business partners, enterprise IS service partners, and vendors.
• Communicate with multiple levels within the organization, highlighting issues and proposing solutions.
• Accountable to elicit and analyze needs identified by business customers and convert them into functional design.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing technology professional we seek is an innovator with these qualifications.

Basic Qualifications :

• Doctorate degree and 2 Information Systems, Manufacturing Process automation / Information system experience OR
• Master's degree and 6 Information Systems, Manufacturing Process automation / Information system experience OR
• Bachelor's degree and 8 Information Systems, Manufacturing Process automation / Information system experience OR
• Associate's degree and 10 Information Systems, Manufacturing Process automation / Information system experience OR
• High school diploma / GED and 12 years of Information Systems, Manufacturing Process automation / Information system experience

Preferred Qualifications :

• Demonstrable experience in a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries.
• Experience with the following product platforms : Automation / Process Control System (PCS), Data Historian and / or Manufacturing Execution System (MES) and / or laboratory systems and / or IS platforms.
• Position requires an in-depth knowledge and hands-on coding experience of Emerson Delta V Platform in particular, and on Rockwell FactoryTalk, Rockwell PLC’s.

Aveva PI Data Historian knowledge is required.

• Kneat platform based C&Q documentation development knowledge a plus.
• Additional experience with Korber MES is a plus.
• Demonstrable understanding of GAMP software development lifecycle, ANSI / ISA-S88 and S95 industry standards and methodologies to establish a PCS and MES implementation and Systems Integration that meets Operations' business requirements.
• Exposure to sophisticated technologies around PAT, APC, AR / VR, Location tracking, Control tower, IIoT, IDA and so on would be an advantage.
• Familiarity with industry standards for software development life cycle methodologies and 21 CFR Part 11.
• Experience with validation and change control methodology.
• Hands-on experience with computerized systems including troubleshooting, reliability and performance improvements.
• Good interpersonal skills with ability to work collaboratively in a team-based environment.
• Understanding of cyber security and manufacturing network principles as applied to operations technologies.
• Demonstrate ability to lead and influence multi-functional teams and embrace a team-based culture.

Thrive

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities including :

• 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.

Apply now

for a career that defies imagination

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

careers.amgen.com Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

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