Job Description

Team Horizon is seeking an OT Systems Engineer (Projects) for a global pharmaceutical for their Mayo site. The successful candidate will support a multi-year software life cycle management initiative involving the refresh of GMP application in the pharmaceutical environment.

Why you should apply:

* This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.

* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

* Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

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 producti

* 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

What you need to apply:

* 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