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Mfg Systems Engineer

3 months ago

Holly Springs, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

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

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be accountable for developing and continuously aligning the site manufacturing data ecosystem with rapidly changing business needs and Amgen Digital, Technology & Innovation (DTI) technical roadmaps.

Seeking candidates who possess expertise in business, and automation systems, information/data management and technical experience in database and data historian technologies and integration tools.

Responsibilities:

  • Own and craft the design and technology of the DTI ecosystem.

  • Support and/or be responsible for the execution of a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and financial management for the portfolio.

  • Crafting Amgen's future Keep track of industry and technology trends, connect, and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry

  • Support the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solution. Lead multiple initiatives and priorities.

  • Effectively manage relationships with DTI service owners, business partners, enterprise DTI service partners, and vendors.

  • Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design.

  • Manage DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.

  • Domestic and international travel up to 25%.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will have these qualifications:

Basic Qualifications:

Masters degree
OR
Bachelors degree and 2 years of systems, engineering and/or Information Techonlogy experience
OR
Associates degree and 6 years of Systems, Engineering and/or Information technologyexperience
OR
High school diploma / GED and 8 years of Systems, Engineering and/or Information technology experience

Preferred Qualifications:

  • 4+ years experience in a manufacturing environment with 2+ years of demonstrated ability in the Pharmaceutical or Biotechnology industries.

  • 2+ years combined experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms.

  • Experience and understanding of Information Systems infrastructure services, fundamentals, and operations (Storage, VMs, Network, Active Directory, etc.).

  • General experience in methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping) is helpful.

  • Experience working with Agile development methodologies.

  • 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.

  • Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by applying technical, project management, and business expertise.

  • 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.

  • Knowledge of industry standards for SDLC methodologies and 21 CFR Part 11.

  • General experience with computer validation and change control methodology.

  • Experience with computerized systems including troubleshooting, reliability, and performance improvements.

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.

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 nowfor a career that defies imagination.

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

careers.amgen.com#AmgenNorthCarolina

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.