Automation Validation Engineer (CSV) – Onsite Role

SimoTechnology

Dublin

Remote

EUR 70,000 - 95,000

Full time

16 hours ago

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Benefits offered by this job

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Job summary

SimoTech in Ireland is seeking a CSV Engineer to join our team for the validation of a Drug Product Facility project in Co. Dublin.

The role requires a minimum of 6 years of experience in developing and validating automation documentation and collaborating with SMEs, vendors, and quality teams to meet regulatory timelines and operational needs. The successful candidate will author and manage C&Q plans, URS, FAT, IOQ, and related reports, ensuring compliance with EU and US regulatory

Qualifications

Minimum 6 years in GMP and validation disciplines.
Experience with C&Q plans, URS, FAT, IOQ and validation docs.
Knowledge of 21 CFR Part 11, Eudralex Annex 11, GAMP 5.
Strong technical understanding of computer systems and PLC automation.
Experience with MES, PI Data Historian, PCS, Lab systems, QBMS.
Kneat experience would be advantageous.
Excellent interpersonal and communication skills.

Responsibilities

Author and manage the C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation and summary reports with cross-functional teams.
Monitor FAT and IOQ execution activities, align with test script intent and resolve protocol issues.
Ensure all automation deliverables comply with regulations and best practices.
Maintain traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, RTM and reports.
Develop and maintain SDLC templates, ensuring validation strategy implementation.
Conduct system walkdowns and verify technical documentation and drawings for accuracy.
Identify risks and recommend improvements to C&Q and automation qualification strategy.