Systems Engineer- 23 month contract
The OT Systems Engineer will play a critical role in supporting a multi-year software lifecycle management initiative within a pharmaceutical manufacturing environment. This position involves developing, installing, and upgrading hardware and software solutions as part of a site-wide systems remediation and modernization project. Onsite in Mayo.
Responsibilities
• Works as part of the project team on the design, installation and configuration of operating systems and other software applications on automated manufacturing systems.
• Works with equipment vendor to design and build of secure, robust, highly available fit-for-purpose and future proofed application environments.
• Design and implement data lifecycle management systems that meet or exceed regulatory expectation in respect of data integrity: data backup regimes and system recovery testing Creation of technical documents required to complete SDLC document set
• Testing and verification of installed software to ensure absence of run time errors or software “bugs”.
• Provision of technical support and direction to Validation Engineers and OT support staff as part of project execution and transfer to production.
• Provision of support for root cause problem solving and the implementation of CAPA’s.
Requirements
• Bachelor’s Degree in Information Technology, Computer Engineering or related discipline / equivalent experience
• 5+ years’ experience in the pharmaceutical/biopharmaceutical sector preferably with sterile filling experience
• Experience with delivering complex projects, ideally related to manufacturing modernisation / manufacturing system upgrades to support business critical process equipment.
• Extensive experience delivering automation projects (PLC and SCADA), with expertise in the following technologies: SCADA, Historian, Thin Client Manager, Active Directory and group policy permissions, XML/XSL, SQL DBA and the development of SQL Queries, Stored Procedures and Reporting
• Extensive hands-on experience Siemens S7 400/1500, Allen Bradley, Rockwell FactoryTalk, iFix, Siemens WinCC, Wonderware
• System Admin Windows 10 and Windows Server 2012/2016/2019/2022
• Proficient undertaking Network Architecture reviews with experience undertaking control network design, configuration and fault finding.
• Demonstratable Cyber Security experience with knowledge of industrial standards S95, S88, ISA18.2, IEC62443, Industry4.0, etc.
• Understanding of OT Data Integrity requirements in OT systems.
• Good analytical skills and a proven ability to problem solve and identify CAPAs for deviations relating to bugs, failures, and non-conformances.
• Strong verbal and written communication skills.
