IT Systems Analyst

Reporting to the Manager, Application Systems, this position will be responsible for providing Tier 2 and Tier 3 support for application-layer issues and owns application-oriented projects including system enhancements, integrations, reporting development, database connectivity, application administration, and security management. The role partners closely with business stakeholders to understand needs, resolve issues, and advance organizational goals through the effective use of technology.

Serve as the IT Subject Matter Expert (SME) for Manufacturing Systems, providing hands-on operational support and project delivery for GxP-regulated platforms including PAS-X (MES), Xuri systems, Blue Mountain (CMMS), and Oracle-integrated manufacturing applications. This role partners closely with Manufacturing, Engineering, Quality, and Validation teams to ensure stable, compliant operations while delivering system enhancements and new capabilities aligned with business needs.

DUTIES AND RESPONSIBILITIES:

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

IT Operations & System Ownership

• Provide day-to-day Tier 2/3 support for Manufacturing Systems, including troubleshooting, configuration, master data management, and vendor coordination.
• Act as IT system owner / SME, ensuring system availability, performance, and compliance with IT policies, SOPs, and GxP requirements.
• Support integrations between Manufacturing Systems and upstream/downstream platforms (e.g., Oracle).
• Maintain system documentation, access controls, audit evidence, and change control artifacts.
• Participate in on-call or off-hours support as required to support manufacturing operations.

Project Delivery & Enhancements

• Lead and execute IT workstreams for Manufacturing Systems projects, including new implementations, upgrades, and process improvements.
• Review business and technical requirements, process flows, test plans, and validation documentation (IQ/OQ/PQ support).
• Coordinate testing, production deployments, and post-implementation stabilization with business stakeholders and vendors.
• Contribute to disaster recovery planning and testing.

Business Partnership & SME Leadership

• Serve as a trusted IT partner to Manufacturing, Engineering, Quality, and Validation teams.
• Translate manufacturing and compliance needs into IT solutions using industry best practices.
• Provide system expertise during audits, inspections, and internal reviews.
• Support user training and knowledge transfer in collaboration with Business System Owners.
• Perform other responsibilities as assigned.

Systems in Scope (Manufacturing & CMC)

• PAS-X - Manufacturing Execution System (MES)
• Xuri Systems - Manufacturing equipment / process support platforms
• Blue Mountain - CMMS / Asset & Calibration Management
• Siemens BMS - Building Management / Manufacturing Environment Monitoring Systems
• Oracle - Manufacturing-related integrations and data flows
• Associated GxP Interfaces supporting manufacturing, engineering, and quality processes

• Bachelor's degree in Information Systems, Computer Science, Engineering, or equivalent experience.

• Prior IT application support or systems analyst experience within pharmaceutical, biotechnology, or regulated manufacturing environments.

• Hands-on experience supporting GxP-regulated manufacturing systems, including participation in computer systems validation activities.

• Experience owning and supporting multiple enterprise applications simultaneously.

• Demonstrated ability to gather requirements, create test artifacts, and support system implementations and ongoing operations.

• Experience with SQL Server, Oracle, LINUX, Windows, ETL/EDI, and integrations.

• Strong analytical and communication skills.

Desirable

• Direct experience with PAS-X (MES), Blue Mountain CMMS, manufacturing equipment systems (e.g., Xuri), and Oracle-integrated environments.
• Experience working with Manufacturing, CMC, or Engineering system landscapes.
• Familiarity with IT SDLC, change management, and pharmaceutical compliance standards (e.g., 21 CFR Part 11).

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus