Our client, a renowned international engineering and commissioning firm, is at the forefront of designing and delivering cutting-edge life sciences and manufacturing facilities across Asia. As demand for healthcare products surges in Japan, they are growing rapidly and now seek a CSV (Computerized System Validation) Engineer to support major pharmaceutical projects in Osaka.

In this role, you’ll lead the validation of GMP-regulated computerized systems across pharmaceutical manufacturing environments. From building management systems (BMS) and laboratory information systems (LIMS) to PLC/SCADA and MES platforms, you’ll play a critical role in ensuring regulatory compliance, system reliability, and data integrity throughout the lifecycle of each system.

You’ll be responsible for authoring and executing validation protocols (including IQ, OQ, PQ), supporting GAMP 5 risk-based approaches, and maintaining robust documentation aligned with FDA 21 CFR Part 11 and EU Annex 11 standards. You’ll work closely with global engineering teams, IT, automation specialists, and local QA stakeholders to deliver systems that meet international GMP expectations.

A background in engineering, computer science, or a related technical discipline is essential, along with experience in the validation of automated systems within GMP-regulated environments. Familiarity with regulatory guidance, audit readiness, and cross-functional collaboration is highly valued. Fluency in English is required, and Japanese language skills will be a strong advantage.

This is a unique opportunity to make a tangible impact on the digital infrastructure of pharmaceutical manufacturing in Japan while working with one of the industry’s most respected engineering consultancies.

To explore further, reach out to Stevan Kottritsch at Invenio Global.
EA Personnel KAH Registration No: R1108948
EA Licence No: 19S9800