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Validation engineer with expertise in isolators and vhp cycle development.

Milano
Commissioning Agents Inc
Ingegnere di validazione
Pubblicato il 10 dicembre
Descrizione

PpWe are now seeking a Validation Engineer to join our growing operations in Italy. The Validation Engineer develops the documentation to support commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment. /p h3Key Responsibilities /h3 ul liDevelop protocols for validation, execution, and reporting at client sites. /li liSupport documentation for commissioning, qualification, and validation of facilities and equipment. /li liWrite and execute isolation qualification protocols, VHP cycle development, and GMP‑based qualification protocols. /li liManage the CQ documentation lifecycle from SLIA generation through to OQ completion. /li liSupport onsite and offsite activities such as FATs, SATs, IOQ, PQ executions, and system walkdowns. /li liProvide cGMP leadership and guidance for the integration and delivery of validation services for Life Sciences clients. /li liProactively identify, troubleshoot, and resolve technical issues related to commissioning and qualification activities. /li /ul h3Requirements /h3 ul liBS or MS in a relevant science or engineering field, or equivalent hands‑on experience. /li liMinimum 3–5 years of experience in commissioning and/or qualification activities in an FDA‑regulated industry. /li liExperience with facilities and equipment startup, walk‑downs, utilities (WFI, RO, HVAC), building automation, FAT/SAT, URS, design review, PID, IQ/OQ/PQ generation and execution. /li liStrong cGMP knowledge, Microsoft Word and Excel proficiency. /li liExcellent technical problem‑solving and troubleshooting skills with a solid understanding of typical project deadlines. /li liAbility to work independently, build and nurture a project team, and manage the CQ documentation lifecycle. /li liProficient in life science manufacturing processes such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent. /li liExcellent oral and written English skills. /li liAvailability for travel throughout Italy and occasional European travel; valid permit to stay in Italy. /li liHigh attention to detail and ability to multitask and take initiative to accomplish assigned tasks accurately by established deadlines. /li /ul h3Equal Opportunity Statement /h3 pLa selezione rispetta il principio delle pari opportunità (l. 903 / 77). /p /p #J-18808-Ljbffr

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Home > Lavoro > Lavoro Ingegneria > Lavoro Ingegnere di validazione > Lavoro Ingegnere di validazione a Milano > Validation Engineer with expertise in isolators and VHP Cycle development.

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