ROLE SUMMARY

Describe the primary purpose of this role as well as the Geographical scope (Global/Regional/Local) and any regulatory responsibilities

As Senior Validation Engineer/ PQ Specialist, and as part of an integrated project team, you drive the PQ preparation and exécution activities of the project ensuring they are completed in accordance with system requirements, specifications, quality attributes and project procedures/ guidelines.

Scope:

• Clean Utilities (water, gas, air, steam, decontamination station)

• Facility Environmental Monitoring (classified area PQ)

• Temperature control units (fridge, freezer, incubator, thawing cabinets, coldrooms, ambient areas)

• Cleaning (Parts Washer cleaning cycle, CHT and DHT)

• Sterilisation (Autoclave sterilisation cycle, SHT)

• Vial Filling (Filling accuracy under grande A)

• Decontamination (VHP isolator, H2O2 classified areas)

• Automation (CSV)

• Media Simulation/ Media Fill (APS)

• Process Confirmation Run (Clinical Manufacturing): Water batch, Mock-up, Engineering runs.