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Principal Automation Engineer (Process)

Regeneron · Limerick, Munster, IE

We are seeking a Principal Automation Engineer to support manufacturing operations at the Raheen site. This Role will require extensive experience in design,...

Job description

We are seeking a Principal Automation Engineer to support manufacturing operations at the Raheen site. This Role will require extensive experience in design, implementation and optimization of automated industrial and manufacturing processes. As a Principal Process Engineer, a typical day might include the following: - Programming, diagnosing, and troubleshooting Emerson DeltaV (ISA‑88 batch), Allen‑Bradley/Rockwell PLCs, and HMI applications for bioreactors, chromatography skids, clean utilities (WFI/clean steam) - Owning full automation project lifecycle: URS, design, FAT/SAT, IQ/OQ/PQ, CSV, and turnover—ensuring robust schedules and coordination with Manufacturing, QA, Validation, and Facilities - Implementing software changes under formal cGMP change control with impact assessments; update SOPs and training materials - Authoring engineering documents, risk assessments (e.g., FMEA), and test plans per GAMP 5; enforce 21 CFR Part 11 and ALCOA+ data integrity (audit trails, electronic signatures, role‑based access) - Providing site support, troubleshooting operations, participating in deviations/CAPA and investigations, and delivering 24/7 on‑call coverage - Maintaining and diagno...