CQV ENGINEER ITALY

2 settimane fa


milano, Italia CAI A tempo pieno

OverviewCAI is a professional services company established in 1996 that serves Life Sciences and Mission Critical industries. We provide accelerated operational readiness and high-performance solutions through our rigorous approach, field-tested processes, and extensive expertise. Our Foundational Principles guide professional and personal conduct: integrity, serving each other, serving society, and investing in our future.ResponsibilitiesDevelop documentation to support Commissioning, Qualifications, and Validation (CQV) at pharmaceutical facilities, utilities, and equipmentWrite and execute protocols, perform field verification, and develop summary reports at client sitesSupport onsite and offsite CQV activities such as FATs, SATs, IOQ, PQ executions, and system walkdownsManage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completionProvide cGMP leadership and guidance for the delivery of CQV services to Life Sciences clientsCollaborate with project teams, build and nurture a project team, and work independently while meeting deadlinesProficiently apply knowledge of life science manufacturing processes (biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent) and related equipmentTravel as required within Italy and possibly other parts of EuropePosition RequirementsBS or MS in a relevant science or engineering field, or equivalent hands-on experienceMinimum 4–8 years of commissioning and/or qualification experience in an FDA-regulated industryExperience with facilities and equipment startup, walkdowns & troubleshooting, utilities (WFI, RO, HVAC), building automation, FAT/SAT, URS, design reviews, P&IDs, IQ/OQ/PQAbility to lead and provide guidance for CQV services; strong technical problem-solving and troubleshooting skillsHigh attention to detail; ability to multi-task and meet deadlines; strong written and verbal EnglishAbility to work independently and build a project team quicklyFamiliarity with Baseline Guide 5 (Second Edition) is a plusExpertise in Microsoft Word and ExcelWillingness to travel (Italy and possibly Europe)Interest in a safe, inclusive work culture and adherence to diverse hiring practicesEEO compliance: La selezione rispetta il principio delle pari opportunità (l. 903/77)#J-18808-Ljbffr


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