Réalta Technologies are searching for an Automation Area Lead to support our Biotechnology client on an ongoing project in Limerick.
The Area Lead is initially required to perform various tasks related to replicating the Delta V documentation and code. They will also participate in selected testing of the code. Following replication, the role will transition to focus on leadership of one particular production area: Upstream, Downstream, or Utilities. The Area Lead will represent the client for any software changes requested by the project (a System Integrator will implement them).
Responsibilities:
* Replicate DeltaV design documentation in Kneat (requirements, design specifications and test documentation) using defined replication tools & methods in compliance with the Automation VP and project schedule.
* Replicate DeltaV software modules using validated tools & methods. Deliver the system software on-time, following the Internal Customer (C&Q and Operations) requirements.
* Maximise leveraging of testing from the Phase 1 project – elimination of re-work to deliver the required time & cost savings for the project (versus Phase 1).
* Maintain oversight of software change control in relevant Areas. Carry out impact assessments, implementation planning, and early-life reviews to confirm change objectives are realized.
* Maintain the controlled document status throughout the project lifecycle. Coordinate review & approval process for all changes/revisions to relevant Area documentation.
* Following replication, coordinate software development & testing by others (System Integrator resources).
* Manage code deployment to the production system for relevant Areas. Prevent/minimize interruption to planned site activities.
* Support the C&Q phase as SME for relevant Areas.
* Support the Operations start-up and PSQ phase through to the PV start.
Requirements:
* At least five years of Automation experience in the Pharma or Biotech industry.
* Detailed knowledge of DeltaV software file structure, parameter configuration, and S88 principles.
* Experience with Source Code Management tools (e.g. Git / GitHub), database comparison tools and software replication techniques. Practical knowledge of application in a regulated process / bio-pharma environment.
* Good understanding of the Computer System Validation life cycle.
* Experience in at least one of the following Areas - Upstream, Downstream or Utilities is a plus.
* Familiarity with the Kneat documentation management system is a plus.
* Excellent reporting & communication skills.
* Experience with Siemens PLC would be a plus.
* Flexibility to travel for FAT’s.
* Demonstrated project team experience on large projects.
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