Amgen is seeking a Specialist IS Engineer at its site in West Greenwich, RI to join the Information Systems team. This position will report to the Sr Manager, Information Systems and will act as the lead technical expert for the new manufacturing plant at the West Greenwich site.
The site Information Systems team supports manufacturing technology that is leveraged across the site. The technical lead provides business and systems analysis expertise, leading the operational readiness activities related to IS for the new plant.
The Specialist IS Engineer plays a critical role in building and maintaining strong business partnership with the manufacturing site leadership team and is a key department liaison with the IS workstream of the plant construction project.
Deliver technical oversight to all application delivery for the manufacturing plant.
Ensure that systems are implemented and maintained in compliance with 21 CFR Part 11 and follows the IS Project Management Lifecycle Methodology.
Management and coordination of third-party organizations such as contractors, engineering firms and consultants, as well as internal, cross-functional area resources.
Coordination of business process and system issues across multiple departments, functions and locations.
Financial management including: budget planning, budget management, and business case development.
Active member of the site IS team, ensure the evolution of a robust multi-site IS support model.
Lead technical root cause analysis, incident investigations, and troubleshooting on computerized systems.
Analyze problems, develop and propose technical solutions in a scientific manner using data-driven techniques and analyses.
Work schedule flexibility to support 24/7 operations, occasional after-hours coverage.
Master's degree and 3 years of Engineering or Information Systems experience
Bachelor's degree and 5 years of Engineering or Information Systems experience
Associate's degree and 10 years of Engineering or Information Systems experience
High school diploma / GED and 12 years of Engineering or Information Systems experience
Bachelor's degree in Engineering, Information Systems, or related technological field
8+ years of experience with operations/manufacturing environment
Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.).
Hands-on experience with computerized systems including troubleshooting, reliability and performance improvements.
Strong leadership, technical writing, and communication/presentation skills
Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
Significant experience leading large projects or IS workstreams.
Experience with teams that span globally or across multiple locations.
Ability to clearly quantify the business value of IT investments through fact-based models.
Management and coordination of third-party organizations such as contractors, engineering firms and consultants.
Previous experience leading strategic planning efforts and the implementation of plans for coordinating multi-site enterprise-wide system solutions.
Implementation experience of software and hardware components within an FDA regulated environment.
Experience with data aggregation and presentation (reporting, dashboards).
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Associated topics: biochemistry, biological engineer, biology, biomedical, bioprocessing, medical, msat, neuro, neuroscience, pain