Cqv Engineer Staff Ii

ph3CQV Engineer Staff II /h3 pAzienda : Caiü, Tipo Lavoro : Full Time, Italy /p h3Descrizione Lavoro - CQV Engineer Staff II /h3 pWe 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. /p pThe role of a CQV Engineer in CAI is to: /p ul liSupport documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. /li liResponsible for protocol writing and execution (field verification), and development of summary reports at client sites. /li /ul h3Position Requirements /h3 ul liHigh attention to detail /li liAbility 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 /li liMinimum 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, PIDs, IQ/OQ/PQs, generation execution, etc. /li liProvide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. /li liExcellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues deadlines /li liAbility to work independently, while quickly building and nurturing a project team /li liManaging the CQ documentation and execution lifecycle from SLIA generation through to OQ completion. /li liSupport onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns /li liProficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. /li liFamiliarity with Baseline Guide 5 (Second Edition) a plus /li liExpected skills: Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge /li liExpertise in Microsoft Word and Excel /li liExcellent oral and written English are required. /li liAvailable for travel in Italy and abroad. /li /ul pLa selezione rispetta il principio delle pari opportunità (l. 903/77) /p pWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. /p h3Informazioni sull'azienda /h3 pCaiü /p pRely on CAI for commissioning services that advance life sciences and mission critical facilities around the world. Contact us to achieve accelerated excellence. /p /p #J-18808-Ljbffr