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 secure, robust, highly available fit-for-purpose and future-proofed application environments.
* Design and implement data lifecycle management systems that meet or exceed regulatory expectations 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 CAPAs.
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 modernization/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 with Siemens S7 400/1500, Allen Bradley, Rockwell FactoryTalk, iFix, Siemens WinCC, Wonderware.
* System Admin Windows 10 and Windows Server 2012/2016/2019/2022.
* Proficient in undertaking Network Architecture reviews with experience in 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.
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