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Validation engineer (pisa)

Pisa
Cai
Ingegnere di validazione
Pubblicato il 4 marzo
Descrizione

We 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 individuals are responsible for protocol writing, field verification, and development of summary reports at the client site. The role of a CQV Engineer in CAI is to : Support documentation for the Commissioning Qualification and Validation of pharmaceutical facilities, utilities, and equipment. Responsible for protocol writing, field verification, and development of summary reports at client sites. Position Requirements : High attention to detail Ability 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. Minimum 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, P&IDs, IQ/OQ/PQs is preferred. Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues. Ability to meet deadlines Ability to work independently while building and nurturing a project team. Manage C&Q documentation and lifecycle from SLIA generation through to OQ completion. Support onsite and offsite activities such as FATs, SATs, IOQ, PQ executions, and system walkdowns. Proficient in life science manufacturing processes, including biotech, aseptic processing, fill/finish, OSD, Gene Therapy, or equivalent experience. Familiarity with Baseline Guide 5 (Second Edition) is a plus Expected Skills : <

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Home > Lavoro > Lavoro Ingegneria > Lavoro Ingegnere di validazione > Lavoro Ingegnere di validazione a Pisa > Validation Engineer (Pisa)

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