Validation Engineer

7 giorni fa

Pisa PI, Italia CAI A tempo pieno

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 : GMP-based knowledge, qualification protocols, reporting, and use of calibration instruments for pharmaceutical equipment testing (autoclaves, HVAC, fume hoods, filling lines, oral solid production equipment). Expertise in Microsoft Word and Excel. Excellent oral and written English skills are required. Suitable candidates must be available for travel throughout Italy, with some European travel possibly required. Key Skills Python, SOC, Debugging, C / C++, FDA Regulations, Minitab, Technical Writing, GAMP, OS Kernels, Perl, cGMP, Manufacturing. Employment Details : Type: Full-Time Experience: 4-8 years Vacancy: 1 Location: Validation Engineer • Pisa, Tuscany, Italy #J-18808-Ljbffr

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