OT Systems Engineer

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 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

 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.


• Demonstrable 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.