As an OT Infrastructure Engineer, you will be a key member of the Global AIS team supporting WuXi Biologics Ireland. In this role, you will partner locally on AIS and OT technologies, managing and optimising OT infrastructure and applications to meet user, quality, and business requirements. You will support the design, integration, and lifecycle maintenance of OT network systems while ensuring compliance within a cGMP environment. This position is responsible for delivering reliable infrastructure services, driving continuous improvement, and supporting cross-functional teams to maintain robust and efficient manufacturing operations.
Essential Duties and Responsibilities
- As a local AIS and OT technology partner, Maintain/Manage OT infrastructure and applications; manage user requirements, annual budget planning and allocation, and inventory management.
- Work with suppliers to design, build and integrate OT network infrastructure, including networks, manufacturing domains, hyperconverged platforms (VMWare, Nutanix, etc.), backup systems, automated infrastructure support tools (e.g., SEPM, NTP, SMTP, File synchronization, RDS licensing, SIEM, Thin Manager, etc.), and various automation applications (OSI PI, SQL Server, Simatic Logon, PM Analyzer, Version Dog and Thin Manager, etc.). Report the progress of the work to the Management team.
- Build services for network infrastructure, including performance monitoring and alerting/backup and recovery/version control and Syslog, etc.
- Review and approve supplier documentation including design specifications, FAT/SAT and HSAT test specifications.
- Work with computer system validation and quality teams to ensure quality compliance in project implementation and operations.
- OT infrastructure lifecycle maintenance, patch management, network management and performance monitoring.
- Plan and install hotfixes, Windows, and other system updates. Planning, implementation and reporting of preventive maintenance, patches, and upgrades on manufacturing system networks.
- Continuous optimization of network infrastructure operations, including computer and account management, automated integration, service optimization, data collection and backup, security audits, etc.
- Draft, review and approve Change Requests, SOPs, Work Instructions and Design Specifications.
- Active participation in daily infrastructure tasks.
- Providing insights and recommendations that align with long-term objectives.
- Ensuring cross-functional collaboration and alignment with overall business strategy and goals.
- Flexibility to take on additional tasks and responsibilities at the discretion of the Global AIS and Local AIS Management.
- Will act as a role model for peers and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Cross-Functional Collaboration:
- Regular inter-departmental meetings to align tasks.
- Working closely with on site and above site senior leaders from manufacturing, quality, engineering and regulatory affairs to identify improvement areas and align efforts.
Continuous Improvement Strategies:
- Developing and implementing continuous improvement strategies across Operational technology environment.
- Utilizing WBS, Lean and Six Sigma methodologies to enhance operational performance.
Technical Expertise and Major Initiatives:
- Providing expert technical support to GMP Manufacturing / Laboratory Operations, engineering and warehouse areas.
Technical Support for GMP Operations:
- Establishing robust technical support systems for GMP Operational Technology environment.
- Troubleshooting issues, implementing programme improvements, and ensuring systems remain validated and compliant at all times.
- Networking with manufacturing and quality organizations to maintain reliable process control for equipment and systems.
Technical Competencies
- Experience with Dell multi-host blade systems, Microsoft Windows Server 2012, 2016 and 2019 experience.
- Virtualization operating experience (VMWare, Nutanix and Hyper-V).
- Experience with thin client software solutions.
- Understand standard documentation systems such as hardware design, network design, FAT and SAT.
- Experience with the Purdue model
- Understand cGMP, especially biopharmaceutical production and automation systems.
Experience
- Degree in IT engineering, or other relevant Qualification or equivalent experience.
- Experience in a cGMP manufacturing environment or biologics process development.
- Experience working on projects and cross-functional initiatives
- Proven ability to work on own initiative in a prior role
- Ability to understand and communicate risks and develop and execute contingency plans
- Extensive experience in the operation of large-scale technology.
- Hands on experience with large scale technology operations.
Knowledge
- In-depth understanding of large-scale technology unit operations.
- Strong knowledge and experience in GMP environment and working within Quality System
- Strong knowledge and experience in project management.
Behavioural Competencies
- Demonstrated ability to organize and support GMP technology systems.
- Strong Communication skills.
- A strong communicator with the ability to work well within a cross-functional team to achieve a common objective.
- Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
- Be collaborative and inclusive in your approach to work and your colleagues.
- Engage cross functionally in conjunction with a site-based team.
- Autonomous and a self-starter who will use their initiative to drive actions forward.
- Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.
WuXi Biologics is an equal opportunities employer.
