Validation Engineer
7 giorni fa
OverviewCAI is a professional services company established in **** that has grown year over year to nearly 800 people worldwide.For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years.CAI Overview and Approach: Our Purpose informs everything we do.We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.We are committed to living our Foundational Principles professionally and personally: we act with integrity, we serve each other, we serve society, and we work for our future.We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.We act with integrityWe serve each otherWe serve societyWe work for our futureAt CAI we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations.Operational readiness is a core focus and a way of life for CAI.ResponsibilitiesKey Responsibilities:Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.Provide cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients.Support onsite and offsite activities, such as FATs, SATs, IOQ and PQ executions and system walkdowns.Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.Experience with facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.Familiarity with Baseline Guide 5 (Second Edition) is a plus.Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues and deadlines.Ability to work independently, while quickly building and nurturing a project team.Position RequirementsHigh attention to detail.Ability to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience.Minimum 4 – 8 years' experience performing commissioning and/or qualification activities in an FDA regulated industry.Travel: Suitable candidates must be available for travel throughout Italy and some European travel may be required.Excellent verbal and written English.Ability to provide CGMP leadership for CQV services.Other requirements and information:DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTEROLa selezione rispetta il principio delle pari opportunità (l. ******)Additional InformationSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Quality AssuranceIndustries: Pharmaceutical Manufacturing#J-*****-Ljbffr
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Validation Engineer
1 settimana fa
Pisa, Italia Altro A tempo pienoOverview CAI is a professional services company established in **** that has grown year over year to nearly 800 people worldwide.For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our...
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Validation Engineer
1 settimana fa
Pisa, Italia CAI A tempo pienoOverviewCAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our...
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Validation Engineer
1 settimana fa
pisa, Italia CAI A tempo pienoOverviewCAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our...
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Validation Engineer
1 settimana fa
pisa, Italia CAI A tempo pienoOverviewCAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our...
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Validation Engineer
4 settimane fa
Pisa, Italia CAI A tempo pienoOverview CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our...
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2 giorni fa
Pisa, Italia CAI A tempo pienoOverview CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our...
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20 ore fa
Pisa, Toscana, Italia CAI A tempo pienoCAI Overview:Are You Ready?CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest...
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