I am currently working with a Leading Global Pharmaceutical client based in the beautiful Cork, Ireland.
Due to a large volume of work and multiple projects on site, the client are looking for a CQ Engineer with Pharmaceutical expertise to joint their existing team.
The CQ Engineer will ideally be based locally and have extensive experience working within an API environment - with Small Volume Continuous Skids, Reactors, Filter Dryers & Nano Filtration Skids.
Skills & Responsibilities:
- The CQ Engineer reports to the CQ Area Lead and is responsible for the safe and compliant delivery of commissioning and qualification for their assigned systems
- Commissioning and Qualification of Process Equipment and Utilities
- Generation of System User Requirements, C&Q Risk Assessments, C&Q plans, test cases and reports.
- Vendor and Contractor coordination and supervision (offsite and onsite),
- Review and acceptance of contractor and vendor handover documentation,
- CQ execution for assigned systems (FAT, SAT, RV, IV, OV),
- Running recipes, sequences and functional testing via DCS,
- Troubleshooting and resolving design, installation and operational issues for systems under test,
- Project Change Control and Discrepancy Management for assigned systems,
- Handover of systems to User Team,
- Adherence to all safety procedures and requirements.
- BS Engineering or Science
- Minimum 5 years project experience in the commissioning and qualification of pharma equipment and utilities.
- Knowledge of Small Molecule Unit Operations, Continuous Manufacturing and/ or ATEX environments is desirable
- Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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