Senior Associate IS Business Systems Analyst

at  Amgen

BASIC QUALIFICATIONS

• Master’s degree in Engineering, Information Systems, Computer Science or Life Sciences OR
• Bachelor’s degree in Engineering, Information Systems, Computer Science or Life Sciences and 2 years of directly related experience OR
• Associate’s degree in Engineering, Information Systems, Computer Science or Life Sciences and 6 years of directly related experience OR
• High school diploma in Engineering, Information Systems, Computer Science or Life Sciences / GED and 8 years of directly related experience
• 5+ years Demonstrated experience of DTI support in a Life Sciences, Pharmaceutical, Biotech company or equivalent industry including business function support to manufacturing, quality/lab and process development.
• Experience supporting GxP computer related systems, computer validation, testing, change control and other GxP System Development Lifecycle (SDLC) activities.
• Experience with Enterprise Systems, Manufacturing, Laboratory and Quality Systems and Instrumentation experience: Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Chromatography Data Systems (CDS), Electronic Laboratory Notebook and/or Method Execution and instrument data capture applications.
• Experience in coordinating work involving vendors and other external parties to provide support for system troubleshooting or new system introductions and enhancements.
• Experience in Data Integrity Assessments (DIA) & Systems Compliance Assessments (SCA).
• Client management skills - ability to work with internal business clients to understand their business processes, manage scope of work expectations and suggest / recommend solutions.
• Strong team player who can collaborate with colleagues on complex tasks and can provide leadership through influence to achieve the required results.
• Able to work independently with minimal supervision and adapt to changing priorities.
• Leadership, project management, communication, analysis, customer service, change management and interpersonal skills (e.g. conflict resolution).
• Understanding of the Safe Agile, ITIL process framework and outsourced resource support models.
• Familiarity with ServiceNow is preferred.

WHAT YOU WILL DO

Daily activities include deploying benchtop systems, responding to end-user requests, break/fix, system upgrades support, system validation support, and coordination of work across different functions and services. In addition, and act as the site Digital Technology and Innovation (DTI) SMEs to coordinate with DTI global for Amgen Singapore Empower Chromatography Data Systems (CDS) in QC and PD, Laboratory Method Execution System (LMES) and Consumable Inventory Management System (CIMS), Laboratory Information Management System (LIMS) and ARRS. This role may be responsible for a secondary system support of other key Manufacturing Systems such as Manufacturing Execution System (MES)

RESPONSIBILITIES:

• Provide routine security administration and technical support to users across multiple plants.
• Provide technical support for upgrade and enhancement projects.
• Troubleshooting application issues and work with systems owners and vendors as needed.
• Support corporate deployments of anti-virus, malware and software patches.
• Contribute to multiple aspects of the system development lifecycle.
• Perform system changes per applicable change control procedures.
• Develop and execute test protocols and procedures.
• Support validation and qualification (IQ, OQ) activities.
• Work with functions stakeholders and vendors to develop and translate computing needs into sustainable, standardized solutions.
• Secondary support for other key manufacturing systems such as Manufacturing Execution System (MES), may be required for business continuity