Pharmaceutical & Biotechnology

OT Systems Engineer

Posted 24 hours ago
Contract
Westport, County Mayo, Ireland
42038265

PE Global is recruiting for an OT Systems Engineer on behalf of our biopharmaceutical client in County Mayo. This is an initial 23-month contract, hybrid role.

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

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.

Administration

Attend twice-weekly Tier 2 department meetings
Attend external meetings as required

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.
Demonstrable Cyber Security experience with knowledge of industrial standards S95, S88, ISA18.2, IEC 62443, Industry 4.0, 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.