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. /ppbThe role of a CQV Engineer in CAI is to : /b /ppSupport documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. /ppResponsible for protocol writing and execution (field verification), and development of summary reports at client sites. /ppPosition Requirements : /ppbHigh attention to detail /b /ppAbility 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 /ppMinimum 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. /ppProvide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. /ppExcellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues /ppbdeadlines /b /ppAbility to work independently, while quickly building and nurturing a project team /ppManaging the CQ documentation and execution lifecycle from SLIA generation through to OQ completion. /ppSupport onsite and offsite activities, such as : FATs, SATs, IOQ and PQ Executions and System Walkdowns /ppProficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill / finish, OSD, Gene Therapy or equivalent experience. /ppbFamiliarity with Baseline Guide 5 (Second Edition) a plus /b /ppuExpected skills : /u Agent expected skills : GMP based knowledge, qualification protocols execution and reporting, use of calibration instruments for pharmaceutical equipment testing (autoclaves, HVAC, fume hood, filling lines, oral solid production equipment). /ppExpertise in Microsoft Word and Excel /ppbExcellent oral and written English are required. /b /ppSuitable candidates must be available for travel throughout Italy and some European travel may be required. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr