Job Title: Systems Engineer
The OT Systems Engineer will play a critical role in supporting a multi-year software lifecycle management initiative within a pharmaceutical manufacturing environment. This position involves developing, installing, and upgrading hardware and software solutions as part of a site-wide systems remediation and modernization project.
Key Responsibilities:
* Works as part of 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, and future-proof application environments.
* Designs and implements data lifecycle management systems that meet or exceed regulatory expectations regarding data integrity, including data backup regimes and system recovery testing.
* Creats technical documents required to complete the Software Development Lifecycle (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 Corrective Actions and Preventive Actions (CAPAs).
Requirements:
* Bachelor's Degree in Information Technology, Computer Engineering, or a related discipline, or equivalent experience.
* 5+ years of 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 with automation projects (PLC and SCADA), including 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.
* Hands-on experience with Siemens S7 400/1500, Allen Bradley, Rockwell FactoryTalk, iFix, Siemens WinCC, Wonderware.
* System administration experience with Windows 10 and Windows Server 2012/2016/2019/2022.
* Proficient in network architecture reviews, including 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.
* Strong analytical skills and a proven ability to problem solve and identify CAPAs for deviations relating to bugs, failures, and non-conformances.
* Excellent verbal and written communication skills.