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Manufacturing Systems Specialist
2 months ago
Your journey to becoming a skilled professional has been remarkable, and now you are poised to elevate your career.
How will you leverage your expertise, experience, and enthusiasm to achieve your aspirations? At Amgen, our collective mission—to serve patients—guides our every action.
This commitment is pivotal to our emergence as a leading biotechnology firm, impacting over 10 million patients globally. Join us in delivering your best alongside other creative, motivated professionals in this impactful role.Be part of Amgen's cutting-edge drug substance manufacturing facility.
Upon completion, the Amgen FleX Batch plant will merge state-of-the-art disposable technologies with conventional stainless-steel systems to maximize operational flexibility.
This facility will not only showcase premier drug substance manufacturing technologies with integrated industry 4.0 capabilities but will also incorporate sustainability innovations aimed at minimizing carbon footprint and waste, aligning with Amgen's goal of achieving carbon neutrality by 2027.
Manufacturing Systems SpecialistLive
Your Responsibilities
Let's embark on this journey together.
In this essential role, you will be responsible for developing and continuously aligning the site manufacturing data ecosystem with evolving business requirements and Amgen Digital, Technology & Innovation (DTI) technical roadmaps.
We are looking for candidates with expertise in business and automation systems, information/data management, as well as technical proficiency in database and data historian technologies and integration tools.
Key Responsibilities:
Lead the design and technology of the DTI ecosystem.
Oversee and/or manage the execution of a diverse portfolio of DTI and automation platform projects, ensuring effective portfolio planning, resource allocation, risk management, and financial oversight.
Support cross-system analysis, feasibility studies, project scoping, prioritize deliverables, and recommend optimal solutions. Manage multiple initiatives and priorities effectively.
Build and maintain relationships with DTI service owners, business partners, enterprise DTI service partners, and vendors.
Accountable for gathering and analyzing needs identified by business stakeholders and translating them into functional designs.
Manage DTI platform activities, including system administration, troubleshooting, vendor management, platform lifecycle, and business requirements.
Domestic and international travel may be required up to 25%.
Win
What We Expect From You
We celebrate our differences and leverage our unique contributions to serve patients.
Qualifications:
Basic Qualifications:
Master's degree
OR
Bachelor's degree with 2 years of experience in systems, engineering, and/or Information Technology
OR
Associate's degree with 6 years of experience in Systems, Engineering, and/or Information Technology
OR
High school diploma/GED with 8 years of experience in Systems, Engineering, and/or Information Technology
Preferred Qualifications:
4+ years of experience in a manufacturing setting, with at least 2 years demonstrating proficiency in the Pharmaceutical or Biotechnology sectors.
2+ years of 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.
General experience in methods and technologies to support Manufacturing Data integrations (e.g., SQL, Web Services/messaging, data mapping) is advantageous.
Experience with Agile development methodologies.
Ability to translate strategic opportunities and emerging technology solutions into actionable plans, while aligning corporate standards with local business needs and project requirements.
Proficient in anticipating, evaluating, and resolving multiple, simultaneous project challenges by applying technical, project management, and business acumen.
Familiarity with GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies for establishing a PCS and MES implementation that meets operational requirements.
General experience with computer validation and change control processes.
Experience with computerized systems, including troubleshooting, reliability, and performance enhancements.
Thrive
What You Can Expect From Us
As we strive to develop treatments that benefit others, we also prioritize the professional and personal growth and well-being of our team members.
Extensive employee benefits package, featuring a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
Stock-based long-term incentives.
Award-winning time-off policies and bi-annual company-wide shutdowns.
Flexible work arrangements, including remote work options where feasible.
Join us in a career that fosters innovation and excellence.
Objects in your future are closer than they appear. Join us.
