Validation Engineer With Expertise In Isolators And Vhp Cycle Development.
2 giorni fa
We 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.Key ResponsibilitiesDevelop protocols for validation, execution, and reporting at client sites.Support documentation for commissioning, qualification, and validation of facilities and equipment.Write and execute isolation qualification protocols, VHP cycle development, and GMP-based qualification protocols.Manage the C&Q documentation lifecycle from SLIA generation through to OQ completion.Support onsite and offsite activities such as FATs, SATs, IOQ, PQ executions, and system walkdowns.Provide cGMP leadership and guidance for the integration and delivery of validation services for Life Sciences clients.Proactively identify, troubleshoot, and resolve technical issues related to commissioning and qualification activities.RequirementsBS or MS in a relevant science or engineering field, or equivalent hands-on experience.Minimum 3–5 years of experience in commissioning and/or qualification activities in an FDA-regulated industry.Experience with facilities and equipment startup, walk-downs, utilities (WFI, RO, HVAC), building automation, FAT/SAT, URS, design review, P&ID, IQ/OQ/PQ generation and execution.Strong cGMP knowledge, Microsoft Word and Excel proficiency.Excellent technical problem-solving and troubleshooting skills with a solid understanding of typical project deadlines.Ability to work independently, build and nurture a project team, and manage the C&Q documentation lifecycle.Proficient in life science manufacturing processes such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent.Excellent oral and written English skills.Availability for travel throughout Italy and occasional European travel; valid permit to stay in Italy.High attention to detail and ability to multitask and take initiative to accomplish assigned tasks accurately by established deadlines.Equal Opportunity StatementLa selezione rispetta il principio delle pari opportunità (l. ********).#J-*****-Ljbffr
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Senior Validation Engineer
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Lazio, Italia Ellab A tempo pienoPronti a dare una svolta alla carriera nel Life Science?Ellab, partner di riferimento per la Compliance nel settore Life Science, è in forte espansione e sta cercando nuovi talenti per rafforzare il Field Services Team a Milano.Il ruolo di Senior Validation Engineer offre l'opportunità di contribuire in modo significativo all'interno di un ambiente...
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Senior Validation Engineer
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