The OT Systems Engineer will play a critical role in supporting a multi-year software lifecycle management initiative within a pharmaceutical manufacturing environment.
Key Responsibilities
* Develops, installs, and upgrades hardware and software solutions as part of a site-wide systems remediation and modernization project.
* Works with the project team on the design, installation, and configuration of operating systems and other software applications on automated manufacturing systems.
* Collaborates with equipment vendors to design and build secure, robust, highly available, fit-for-purpose, and future-proofed application environments.
* Designs and implements data lifecycle management systems that meet or exceed regulatory expectations for data integrity, including data backup regimes and system recovery testing.
* Creates technical documents required to complete the SDLC document set.
* Tests and verifies installed software to ensure the absence of runtime errors or software bugs.
* Provides technical support and direction to Validation Engineers and OT support staff during project execution and transfer to production.
* Supports root cause problem-solving and the implementation of CAPAs.
Requirements
* Bachelor's Degree in Information Technology, Computer Engineering, or a related discipline/equivalent experience.
* 5+ years' experience in the pharmaceutical/biopharmaceutical sector, preferably with sterile filling experience.
* Experience 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 technologies such as:
o SCADA
o Historian
o Thin Client Manager
o Active Directory and group policy permissions
o XML/XSL
o SQL DBA and the development of SQL Queries, Stored Procedures, and Reporting
* 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 undertaking Network Architecture reviews with experience undertaking control network design, configuration, and fault finding.
* Demonstratable Cyber Security experience with knowledge of industrial standards such as 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.