Job description
Orion Group Life Sciences are currently recruiting OT Systems Engineer on behalf of our Multinational Biopharmaceutical client based in Westport on an initial 23-month contract with huge potential to extend.
JOB SUMMARY:
Operational Technology (OT) System Engineer is required to support a multi-year software lifecycle management initiative involving the refresh of GMP applications in the Pharmaceutical environment. The OT Systems Engineer will be expected to support all aspects of the development and installation of new hardware and software solutions as part of site wide systems remediation/upgrade project.
Responsibilities
Business Unit Support
1. Works as part of the project team on the design, installation and configuration of operating systems and other software applications on automated manufacturing systems.
2. Works with equipment vendor to design and build secure, robust, highly available fit-for-purpose and future proofed application environments.
3. Design and implement data lifecycle management systems that meet or exceed regulatory expectations in respect of data integrity, including data backup regimes and system recovery testing.
4. Creation of technical documents required to complete SDLC document set.
5. Testing and verification of installed software to ensure absence of run time errors or software "bugs".
6. Provision of technical support and direction to Validation Engineers and OT support staff as part of project execution and transfer to production.
7. Provision of support for root cause problem solving and the implementation of CAPAs.
Administration
1. Attend twice-weekly Tier 2 department meetings.
2. Attend external meetings as required.
Requirements
1. Bachelor's Degree in Information Technology, Computer Engineering or related discipline / equivalent experience.
2. 5+ years' experience in the pharmaceutical/biopharmaceutical sector preferably with sterile filling experience.
3. Experience with delivering complex projects, ideally related to manufacturing modernisation / manufacturing system upgrades to support business critical process equipment.
4. 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.
5. Extensive hands-on experience with Siemens S7 400/1500, Allen Bradley, Rockwell FactoryTalk, iFix, Siemens WinCC, Wonderware.
6. System Admin Windows 10 and Windows Server 2012/2016/2019/2022.
7. Proficient in undertaking Network Architecture reviews with experience in control network design, configuration, and fault finding.
8. Demonstratable Cyber Security experience with knowledge of industrial standards S95, S88, ISA18.2, IEC62443, Industry4.0, etc.
9. Understanding of OT Data Integrity requirements in OT systems.
10. Good analytical skills and a proven ability to problem solve and identify CAPAs for deviations relating to bugs, failures, and non-conformances.
11. Strong verbal and written communication skills.
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