02 ott - Roma
Caiü
CQV Engineer Staff II
Azienda : Caiü, Tipo Lavoro : Tempo pieno, Italy
Descrizione Lavoro - CQV Engineer Staff II
We are now seeking a CQV Engineer to join our growing operations in Italy. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
The role of a CQV Engineer in CAI is to:
Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
Position Requirements
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands‑on experience
Minimum 4 – 8 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally,
you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs;, IQ/OQ/PQs, generation & execution, etc.
Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues deadlines
Ability to work independently, while quickly building and nurturing a project team
Managing the C&Q; documentation and execution lifecycle from SLIA generation through to OQ completion.
Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
Proficient in life science manufacturing processes in areas such as biotech, aseptic p
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