Senior IT Systems Engineer

Description

• Partner with site stakeholders to understand business processes, operational challenges, compliance needs, and improvement opportunities.
• Translate business needs into user requirements, functional specifications, process flows, test scenarios, acceptance criteria, support models, and implementation documentation.
• Facilitate alignment between business users, technical teams, vendors, Quality and global IT.
• Support solution evaluation, proof of concept, business case input, prioritisation, and roadmap planning for Brisbane site manufacturing IT/OT needs.
• Lead or contribute to Brisbane site IT projects involving manufacturing applications, GxP platforms, infrastructure dependencies, compliance remediation, and digital improvements.
• Define scope, requirements, risks, assumptions, dependencies, timelines, documentation needs, testing approach, and deployment readiness.
• Ensure timely and on-budget delivery, design, development, testing, adaptation, and support for IT projects across manufacturing and other GxP Environments.
• Apply appropriate project delivery methods, such as SDLC, Agile, Waterfall.
• Provide clear status updates, risk escalation, issue tracking, decision support, and handover documentation.
• Implement, maintain, and support manufacturing applications, GxP systems, (SCADA, Data Historian, MES, eLogs), data interfaces, and associated infrastructure dependencies.
• Support day-to-day operations through incident management, service requests, troubleshooting, root cause analysis, major incident management and problem management through ServiceNow.
• Collaborate with Manufacturing, Engineering teams, various (global) IT teams and vendors to quickly resolve IT system issues, minimizing business impact, maintaining system availability and reliability.
• Support application lifecycle activities, including upgrades, patching coordination, access reviews, testing, migration, and retirement planning.
• Support IT Compliance and Quality to generate, review, approve, and control departmental documentation (e.g. SOPs, specifications, etc.) and assist with internal and external quality audits.
• Ensures implementation of and adherence to current GMP rules, Quality policies, procedures and instructions for his/her area of responsibility.
• Ensures contribution and support of periodic reviews such as audit trail reviews, access reviews and other GxP related reviews.
• Ensure data integrity compliance participating to site’s “Data Integrity Team”, sustaining, and sharing standard processes, supporting site’s Data Integrity initiatives.

Qualifications

• Bachelor’s degree in computer science or equivalent.

Experience

• At least 5 years’ experience in IT business analysis, manufacturing IT, application support, IT project delivery, or systems engineering.
• Experience in a GMP, pharmaceutical, biotechnology, life sciences, healthcare manufacturing, or another regulated manufacturing environment would be ideal

Knowledge, Skills, Abilities

• Experience with manufacturing application support involving SCADA, MES and Historian related systems and products.
• Comprehensive understanding of IT infrastructure components such as workstations, servers, network devices and manufacturing automation system management.
• Experience working with Virtual environment technology such as VMWare or HyperV.
• Strong experience in requirements gathering, process mapping, IT project management, application deployments and translating business needs into IT solutions.
• GMP experience and/or experience deploying, maintaining, and developing validated systems in regulated environments preferred.
• Ability to work in a team structure, make decisions, solve problems, communicate inside & outside the organization, and analyse, plan, organize and prioritize work
• Dynamic, hard-working and ambitious, with excellent oral and written communication skills.
• Capable of working on multiple projects of a complex nature.
• Excellent problem-solving skills to assist in issue resolution.
• Excellent verbal and written communication skills.