[ref. i80403102] CQV Engineer - Clean Room
Hobson Prior is seeking a dedicated CQV Engineer - Clean Room to join the team in Melbourne. This role focuses on the commissioning and qualification of process equipment and cleanrooms, particularly within vaccine manufacturing systems. The ideal candidate is someone with a strong technical background who can provide expertise in lifecycle deliverables and regulatory compliance.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Oversee commissioning and qualification of process equipment and cleanrooms.
- Prepare and execute C&Q documents, including risk assessments and validation plans.
- Conduct HVAC commissioning and qualification for sterile and non-sterile facilities.
- Perform smoke studies and qualify UDAF/laminar airflow systems.
- Provide technical support and guidance in protocol preparation and execution.
- Manage protocol deviations, including root cause analysis and corrective actions.
- Validate new cleanrooms and perform associated validation activities.
- Verify drawings, layouts, and installation checks for cleanrooms/HVAC.
- Conduct operational and performance tests for cleanrooms/HVAC.
- Coordinate commissioning and qualification activities with cross-functional teams.
- Ensure compliance with industry standards and regulations.
Key Skills and Requirements:
- Proficiency in commissioning and qualification of manufacturing systems.
- Experience with equipment lifecycle activities and document preparation.
- Knowledge of HVAC systems and facility qualification.
- Strong technical writing and communication skills.
- Familiarity with EU GMP, US FDA, WHO, ISPE, and other regulatory guidelines.
- Ability to handle key validation instruments like photometers and particle counters.
- Strong interpersonal skills and ability to work collaboratively.
For more information, please contact Jack Keens.
Apply now
If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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