Ph3Overview /h3pCAI 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 rigorous approach, field tested processes, and elite expertise developed over 30 years. /ppCAI 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. /pulliWe exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. /li /ululliWe act with integrity /liliWe serve each other /liliWe serve society /liliWe work for our future /li /ulpAt 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. /p h3Responsibilities /h3pKey Responsibilities: /pul liSupport documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. /li liResponsible for protocol writing and execution (field verification), and development of summary reports at client sites. /li liProvide cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients. /li liSupport onsite and offsite activities, such as FATs, SATs, IOQ and PQ executions and system walkdowns. /li liManaging the CQ documentation and execution lifecycle from SLIA generation through to OQ completion. /li liExperience 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, PIDs, IQ/OQ/PQs, generation execution, etc. /li liFamiliarity with Baseline Guide 5 (Second Edition) is a plus. /li liProficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. /li liExcellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues and deadlines. /li liAbility to work independently, while quickly building and nurturing a project team. /li /ul h3Position Requirements /h3ul liHigh attention to detail. /li liAbility 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. /li liMinimum 4 – 8 years’ experience performing commissioning and/or qualification activities in an FDA regulated industry. /li liTravel: Suitable candidates must be available for travel throughout Italy and some European travel may be required. /li liExcellent verbal and written English. /li liAbility to provide CGMP leadership for CQV services. /li /ul pOther requirements and information: /pul liDISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO /li liLa selezione rispetta il principio delle pari opportunità (l. 903/77) /li /ul h3Additional Information /h3ul liSeniority level: Mid-Senior level /li liEmployment type: Full-time /li liJob function: Quality Assurance /li liIndustries: Pharmaceutical Manufacturing /li /ul /p #J-18808-Ljbffr