Job DescriptionAutomation Area Lead required for Biotech client based in Limerick.
Contract role.ResponsibilitiesReplicate 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.
JRequirements: The Area Lead should have / possess the following:
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.