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Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.
The ideal candidate will focus on the process, validation, and how the unit ties into existing building services, utilities and cleanroom systems, and act as the technical point of contact for this area.
Responsibilities: Optimise NO2 sterilisation cycle parameters.
Troubleshoot issues and ensure the process runs reliably and consistently.
Work with the equipment supplier on technical and process matters.
Support or lead IQ, OQ and PQ activities.
Develop and run cycle validation, including BI studies and worst-case conditions.
Optimise key process parameters (e.g.
gas concentration, exposure time).
Prepare and review validation documents in line with GMP and Annex 1.
Review results, manage deviations, and support requalification work. xyswxtq
Ensure the approach fits with the sites contamination control strategy and facility setup (e.g.
HVAC).
Ensure the unit is properly integrated with existing systems, including: HVAC and cleanroom pressures, exhaust and abatement systems and BMS, alarms and safety interlocks Review P&IDs and layouts from a process point of view Assess any impact on cleanroom performance and contamination control Support risk assessments (e.g.
HAZOP) relating to NO2 use and safety Qualifications & Experience: Degree in a relevant field is essential Experience with sterilisation processes (NO2, VHP, EtO or similar) Strong background in GMP validation (IQ/OQ/PQ) Good understanding of cleanrooms, HVAC and facility systems Experience bringing equipment into an existing pharma site
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Sprachkenntnisse
- English
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