Manufacturing Systems Engineer - MES

Role Summary

Manufacturing Systems Engineer - MES is responsible for developing and continuously aligning the site manufacturing data ecosystem with rapidly changing business needs and Amgen Digital, Technology & Innovation (DTI) technical roadmaps. This role entails coordinating DTI and automation platform initiatives, working with service owners, business partners, and vendors to ensure PCS and MES implementations meet Operations' requirements. Domestic and international travel up to 25% may be required.

Responsibilities

• 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. 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.
• 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.
• Manage DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
• Domestic and international travel up to 25%.

Qualifications

• Required: Doctorate degree OR Master’s degree and 2 years of Information Systems, Engineering and/or Information technology experience, OR Bachelor’s degree and 4 years of Information Systems, Engineering and/or Information technology experience, OR Associate's degree and 8 years of Information Systems, Engineering and/or Information technology experience, OR High school diploma/GED and 10 years of Information Systems, Engineering and/or Information technology experience.
• Preferred: 4+ years’ experience in a manufacturing environment with 2+ years of demonstrated ability in the Pharmaceutical or Biotechnology industries.
• Preferred: 2+ years’ combined experience with the following product platforms: MES (Korber), Passwordless Authentication, Data Historian (OSI PI), and/or IS platforms.
• Preferred: Own and craft the design and technology of the DTI ecosystem.
• Preferred: Experience and understanding of Information Systems infrastructure services, fundamentals, and operations (Storage, VMs, Network, Active Directory, etc.).
• Preferred: General experience in methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping) is helpful.
• Preferred: Experience working with Agile development methodologies.
• Preferred: 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.
• Preferred: Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design.
• Preferred: Knowledge of industry standards for SDLC methodologies and 21 CFR Part 11.
• Preferred: General experience with computer validation and change control methodology.
• Preferred: Experience with computerized systems including troubleshooting, reliability, and performance improvements.