Job Description The Manufacturing Execution System (MES) Senior Engineer is responsible for providing project leadership and daily operational support to the Automation Engineering team at the Amgen Rhode Island site. Specific duties include: Manages and/or applies extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes. Develop, organize, analyze, and present results for operational issues and MES projects of moderate scope and complexity Work closely with multiple disciplines, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to manage a diverse portfolio of projects Provide technical support to commercial and clinical manufacturing as needed Develop and execute strategic initiatives for long-range planning and lifecycle upgrades of MES architecture. Activities include managing a 5 year roadmap, presenting high level scope and cost estimates to Information Systems leadership for annual capital funding plan, and project management of initiatives once approved for execution. Provide mentorship to cross-functional Information Systems and Automation Engineering teams in daily operations Provide system ownership, ensuring optimal and cost-effective performance and reliability along with cGMP compliance. Communicate proactively with multiple levels within the organization, highlighting issues and proposing solutions. Provide technical support and issue resolution 24x7 on-call support
Additional Information Basic Qualifications Doctorate degree OR Master’s degree & 3 years of IS experience OR Bachelor’s degree & 5 years of IS experience OR Associate’s degree & 10 years of IS experience OR High school diploma / GED & 12 years of IS experience Preferred Qualifications Bachelor’s Degree or Master’s Degree in Chemical or Computer Engineering or related technical field 2+ years’ experience in MES or Automation Engineering in a manufacturing support environment Excellent written and verbal communication skills and the ability to work with minimum direction. Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team based environment. Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services and non-GMP Utilities. System lifecycle management, both hardware and software, with direct validation and change control experience Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs. Direct hands-on experience with MES system architecture Areas of experience: PAS|X application, Oracle Databases and JBOSS application server, Preferred experience with Scanners, Zebra printers, and Scales, Electronic Batch Record (EBR), Weighing and Dispensing, Equipment Management, SQL knowledge, Reporting capabilities, and Maintain interfaces with other s

Desired Skills and Experience

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