Amgen - Holly Springs, NC

posted about 1 month ago

Full-time - Mid Level
Hybrid - Holly Springs, NC
Chemical Manufacturing

About the position

The Senior Manufacturing Systems Engineer at Amgen will play a crucial role in the company's newest drug substance manufacturing plant, the FleX Batch facility. This position focuses on driving program success through effective project management, ensuring alignment between business and technology leaders, and optimizing processes to enhance efficiency and quality. The role involves overseeing various digital platforms and leading projects that integrate advanced manufacturing technologies and sustainability innovations.

Responsibilities

  • Oversee, manage and maintain various digital platforms, such as DeltaV, Korber MES, Siemens BAS, Enlighted, Rockwell Automation Platform, AR/VR, Electronic Forms, and more.
  • Act as the primary DTI contact for the business, offering platform support and digital solutions.
  • Lead the execution of diverse digital platform projects, ensuring proper portfolio planning, resource allocation, risk management, and financial oversight.
  • Stay updated on industry and technology trends and build external networks to gain valuable insights from peers in the industry.
  • Conduct cross-system and feasibility analyses, define project scopes, prioritize deliverables, and recommend optimal solutions.
  • Manage multiple initiatives and priorities effectively.
  • Foster strong relationships with digital platforms service owners, business partners, enterprise service partners, and vendors.
  • Gather and analyze business stakeholder needs, translating them into functional designs.
  • Handle digital platform activities, including system administration, troubleshooting, vendor management, platform lifecycle management, and addressing business requirements.

Requirements

  • Doctorate degree, OR Master's degree and 2+ years of Information Systems/Technology and/or Engineering experience, OR Bachelor's degree and 4+ years of Information Systems/Technology and/or Engineering experience, OR Associate's degree and 8+ years of Information Systems/Technology and/or Engineering experience, OR High school diploma/GED and 10+ years of Information Systems/Technology and/or Engineering experience.
  • Experience in a manufacturing environment, with more than 5 years of proven expertise in the Pharmaceutical or Biotechnology industries.
  • Proficient in handling and managing computerized systems, including troubleshooting, enhancing reliability, and improving performance.
  • Solid understanding of Information Systems infrastructure services fundamentals and operations, such as Storage, VMs, Network, Active Directory, etc.
  • Familiarity with methods and technologies supporting Manufacturing Data integrations, including SQL, Web Services/messaging, and data mapping, is a plus.
  • Experienced in working with Agile development methodologies.
  • Capable of translating strategic opportunities and emerging technology solutions into practical, executable plans, while aligning corporate blueprints and standards with local business needs and project requirements.
  • Skilled in anticipating, evaluating, and resolving multiple, simultaneous project issues, delays, and problems by applying technical, project management, and business expertise.
  • Knowledgeable about industry standards for SDLC methodologies and 21 CFR Part 11.
  • Experienced in computer validation and change control methodology.

Nice-to-haves

  • Experience in a manufacturing environment, particularly in the Pharmaceutical or Biotechnology industries.
  • Familiarity with Manufacturing Data integrations, including SQL and data mapping.
  • Experience with Agile development methodologies.

Benefits

  • A 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.
  • Flexible work models, including remote and hybrid work arrangements, where possible.
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