PWe are now seeking a bCQV Engineer /b to join our growing operations in Italy. The CQV Engineer develops the documentation to support Commissioning Qualifications and Validation. These individuals are responsible for protocol writing, field verification, and development of summary reports at the client site. /ph3The role of a CQV Engineer in CAI is to : /h3ulliSupport documentation for the Commissioning Qualification and Validation of pharmaceutical facilities, utilities, and equipment. /liliResponsible for protocol writing, field verification, and development of summary reports at client sites. /li /ulh3Position Requirements : /h3ullibHigh attention to detail /b /liliAbility to multitask and take initiative to accomplish assigned tasks accurately, with a BS or MS in a relevant science or engineering field, or equivalent hands-on experience. /liliMinimum 4-8 years experience performing commissioning and/or qualification activities in an FDA-regulated industry. Experience in facilities and equipment startup, walkdowns, troubleshooting utilities (WFI, RO, HVAC), building automation, pharmaceutical manufacturing processes, FAT/SAT, URS design review, PIDs, IQ/OQ/PQs is preferred. /liliProvide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. /liliExcellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues. /lilibAbility to meet deadlines /b /liliAbility to work independently while building and nurturing a project team. /liliManage CQ documentation and lifecycle from SLIA generation through to OQ completion. /liliSupport onsite and offsite activities such as FATs, SATs, IOQ, PQ executions, and system walkdowns. /liliProficient in life science manufacturing processes, including biotech, aseptic processing, fill/finish, OSD, Gene Therapy, or equivalent experience. /lilibFamiliarity with Baseline Guide 5 (Second Edition) is a plus /b /li /ulh3Expected Skills : /h3pGMP-based knowledge, qualification protocols, reporting, and use of calibration instruments for pharmaceutical equipment testing (autoclaves, HVAC, fume hoods, filling lines, oral solid production equipment). /ppExpertise in Microsoft Word and Excel. /ppbExcellent oral and written English skills are required. /b /ppSuitable candidates must be available for travel throughout Italy, with some European travel possibly required. /ph3Key Skills /h3pPython, SOC, Debugging, C / C++, FDA Regulations, Minitab, Technical Writing, GAMP, OS Kernels, Perl, cGMP, Manufacturing. /ph3Employment Details : /h3ulliType: Full-Time /liliExperience: 4-8 years /liliVacancy: 1 /li /ulpLocation: Validation Engineer • Pisa, Tuscany, Italy /p #J-18808-Ljbffr