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Validation engineer

Pisa
Cagents
Ingegnere di validazione
Pubblicato il Pubblicato 12h fa
Descrizione

PCAI is a professional services company established in 1996 with nearly 800 employees worldwide. We serve the Life Sciences and Mission Critical industries by delivering critical solutions in high-stakes environments through rigorous processes, field-tested methods, and elite expertise developed over 30 years. /ppOur Purpose guides us: /pp· To be the trusted solution for our clients as they build a better working world and improve the human experience. /ppWe uphold our Foundational Principles: /pp· Act with integrity /pp· Serve each other /pp· Serve society /pp· Work for our future /ppWe are dedicated to excellence, innovation, and redefining industry standards. We operate at the intersection of wisdom, technology, and humanity, with operational readiness as our core focus. We strive for continuous advancement through precision, efficiency, and a forward-thinking mindset. /ph3Key Responsibilities: /h3olliSupport documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. /liliWrite and execute protocols, develop summary reports at client sites. /liliProvide cGMP leadership for CQV services in Life Sciences. /liliTroubleshoot and resolve technical issues related to facilities and equipment startups. /liliManage the lifecycle of CQ documentation from start to finish. /liliSupport onsite and offsite activities such as FATs, SATs, IQ/OQ/PQ executions, and system walkdowns. /liliPossess knowledge of biotech, aseptic processing, fill/finish, OSD, Gene Therapy, or similar manufacturing processes. /li /olpQualifications include a relevant science or engineering degree or equivalent experience, 4-8 years in FDA-regulated commissioning/qualification, proficiency in GMP protocols, and ability to travel across Italy and Europe. Excellent communication skills in English are required. /ppAdditional skills involve strategic planning, customer focus, leadership, influence, talent development, results orientation, and safe, courageous leadership. /ppThis job is active and accepting applications. /p #J-18808-Ljbffr

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