CQV Engineer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cxnjx

ph3Responsibilities /h3 ul liDevelop the documentation to support Commissioning, Qualifications, and Validation. /li liResponsible for protocol writing and execution, field verification, and development of summary reports at client sites. /li liSupport documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. /li /ul h3Requirements /h3 ul liHigh attention to detail. /li liAbility to multi-task and take initiative to accomplish assigned tasks accurately. /li liEstablished BS or MS in a relevant science or engineering field, or equivalent years of hands‑on experience. /li liMinimum 2–3 years’ experience performing commissioning and/or qualification activities in an FDA regulated industry. /li liExperience in facilities and equipment startup, walkdowns 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 Life Sciences clients.



/li liExcellent technical problem‑solving and troubleshooting skills, with solid knowledge of typical project technical issues. /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) is 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 is required. /li liAvailable for travel in Italy and abroad. /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cxnjx