CQV Engineer
CAI
Overview
As a CQV Engineer in Italy, you will develop and execute documentation for commissioning, qualification, and validation of facilities, utilities, and equipment. You will write protocols, perform field verifications, and craft summary reports at client sites, supporting cGMP-compliant CQV services. You’ll lead the CQV documentation lifecycle from SLIA generation to OQ completion and collaborate with cross-functional teams to deliver validated systems. This role offers hands-on problem solving in a regulated life sciences environment with global travel. You will help ensure reliable, compliant startup and operation of critical manufacturing assets.
Responsabilità- Support CQV documentation for commissioning, qualification, and validation activities
- Write and execute protocols and perform field verifications
- Develop summary reports at client sites
- Manage CQV lifecycle from SLIA generation to OQ completion
- Support on-site and off-site activities including FATs, SATs, IOQ and PQ executions and system walkdowns
- Provide cGMP leadership for CQV services delivery
- Work with life sciences processes and equipment startup, walkdowns, and troubleshooting
- Assist with design reviews, URS, P&IDs, and IQ/OQ/PQ documentation and execution
- BS or MS in a relevant science or engineering field, or equivalent experience
- 4–8 years’ experience in commissioning/qualification in an FDA-regulated industry
- Experience with facilities and equipment startup, walkdowns, utilities (WFI, RO, HVAC), FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs
- Proficient in life science manufacturing processes (biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy)
- Baseline Guide 5 (Second Edition) familiarity is a plus
- Isolators qualification protocols execution and reporting, VHP cycle development, GMP knowledge (preferred)
- Excellent MS Word and Excel skills
- Strong English (oral and written)
- Willingness to travel within Italy and abroad
- strong problem-solving skills
- excellent written and verbal communication
- ability to work independently and build a project team
- CQV documentation and protocol writing
- field verification and system walkdowns
- FAT/SAT/IOQ/PQ execution
Offerta di lavoro pubblicata 1 giorno fa
Offerte di lavoro simili
34.000 € - 45.000 €
...Position Description: We are now seeking a CQV Engineer to join our growing operations in Italy. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field...ConsigliatoTempo pieno- pEFOR sta selezionando un professionista CQV a Milano per coordinare attività CQV su impianti farmaceutici/biotech e redigere documentazione Chiave come URS, DQ, IQ, OQ e PQ. Il ruolo prevede supporto operativo, audit e collaborazione con i team di qualità, produzione e...ConsigliatoImpiego permanente
- pulliGestione e coordinamento delle attività di Commissioning, Qualification e Validation (CQV) per impianti e attrezzature farmaceutiche /liliRedazione e revisione di documentazione tecnica (protocollo, report, SOP, URS, DQ, IQ, OQ, PQ) /liliSupporto all’esecuzione di...ConsigliatoImpiego permanenteTurniWeekend
- ...CAI Milano is seeking a CSV Engineer to develop and execute computer systems validation protocols for life sciences projects in a hybrid role. You will write GxP validation documentation and ensure compliance with 21 CFR Part 11 while collaborating with a global client...ConsigliatoLavoro ibrido
- Per solida realtà industriale, LEADER INTERNAZIONALE nella progettazione, produzione e installazione di impianti per la colata e la laminazione continua di metalli non ferrosi, riconosciuta per l’elevato know-how ingegneristico, l’affidabilità tecnologica e la capacità ...ConsigliatoImpiego permanenteRemoto
Modulo Group Srl
Milano2 mesi fa - ...semiconductor team and help shape the next generation of consumer and automotive integrated circuits. As a Digital Verification Engineer , you will verify advanced Mixed-Signal and System-on-Chip (SoC) ASICs using state-of-the-art verification methodologies, leading...Tempo pienoOrario flessibile40 h/sett.
- ...CSV Life Science Group , an international engineering company, market leader in the pharmaceutical sector, is looking for a Validation Specialist to join its CQV team in Milan and Latina offices. The resource will be placed on a permanent contract. Grade level and...Smart workingTempo pienoImpiego permanenteOrario flessibile
- ph3Executive search in renewable energy | PV BESS specialist | Hiring across origination, business development, project development, engineering… /h3pbPosition: Commissioning Engineer /b /ppbWho are we recruiting for? /b /ppOur client is a globally renowned organization...
- ...Overview Join Bosch Sensortec's international semiconductor team as a Digital Verification Engineer to verify advanced mixed-signal and SoC ASICs. You will build scalable verification environments, apply cutting-edge techniques, and collaborate across global locations...
50.000 € - 55.000 €
At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry...30.000 € - 40.000 €
ph3Ali Professional ricerca Commissioning engineer - Nord Italia /h3 pper importante realtà internazionale leader nel settore impiantistico e del trattamento acque, attiva nella progettazione, realizzazione e gestione di impianti industriali complessi. /p pLa figura sarà...Stage/Tirocinio45.000 € - 50.000 €
...Your responsibilities As commissioning Engineer, you will be responsible for the commissioning of our Green Hydrogen modules and conduction of on-site service for balance of plant and our Chlor-Alkali business. Specifically, you will have to deal with the following...Smart workingOrario flessibile- ...primaria realtà specializzata in consulenza e ingegneria per l'industria farmaceutica, siamo alla ricerca di 2 Validation Specialist / Engineer da inserire all'interno dell'area Validazione (a diretto riporto del Validation Manager) . L'azienda si distingue per un'...Tempo pienoAuto aziendale
25.000 € - 35.000 €
...ISS International S.p.A. ricerca un/una Commissioning Engineer per attività di commissioning nell’ambito di un importante progetto industriale del settore Energy / Oil & Gas , con base operativa presso gli uffici di Milano , Smart Working e trasferte presso un...Smart workingTempo determinatoVitto e alloggio8 h/giorno5 giorni/sett.- ...semiconductor team and help shape the next generation of consumer and automotive integrated circuits. As a bDigital Verification Engineer /b, you will verify advanced Mixed-Signal and System-on-Chip (SoC) ASICs using state-of-the-art verification methodologies, leading...Orario flessibile40 h/sett.
- ...Freelance Commissioning Engineer - Data Centre Project - Italy We are currently supporting a major hyperscale Data Centre project in Northern Italy and are looking to speak with experienced Commissioning Engineers for a long-term freelance assignment. The role...Libero professionistaLungo termine
- ...Fai la differenza con AYES: unisciti come Software Validation Engineer! AYES, multinazionale di consulenza ingegneristica e tecnologica, in vista dell'espansione delle proprie attività in Italia, è alla ricerca di un Senior Software Validation Engineer! AYES opera...
25.000 €
ppbSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? /b /p pbPQE Group /b è affermata in questo settore dal b1998 /b, garantendo una presenza internazionale grazie alle b45 filiali /b e i b2000...Impiego permanenteTempo determinatoWeekend2 giorni/sett.Dal lunedì al venerdì- ph3Role Overview /h3 pThe Senior Commissioning Engineer is responsible for leading the end-to-end commissioning of Fluence energy storage projects across EMEA and globally. This role ensures that all systems are tested, validated, and integrated in accordance with technical...Stage/Tirocinio
25.000 € - 35.000 €
...ISS International Spa è alla ricerca di un Commissioning Engineer in modalità ibrida: 60% da remoto e i restanti 40% in presenza presso gli uffici di Milano. Main Tasks: Develop, update, and maintain the commissioning schedule in alignment with engineering, construction...TemporaneoTempo pienoTempo determinatoLavoro ibridoRemoto- Overview In this role you will oversee performance measurement and KPI-driven governance for the TDS organization. You will ensure the application of standard processes, develop reusable test patterns, and promote continuous improvement within project teams. You will ...
- ...V activities across the project lifecycle for small satellites, ensuring alignment with schedule and budget. You work with system engineers to shape verification strategies, design verification plans, and testing infrastructure. You drive methodical, MBSE-informed processes...Stage/Tirocinio
- ...Overview As a Digital Verification Engineer at Bosch Sensortec, you verify complex mixed-signal and SoC ASICs using advanced methodologies, state-of-the-art tools, and AI-assisted workflows. You will build scalable verification environments and drive first-time-right...
40.000 € - 50.000 €
...offrendo soluzioni customizzate ad alto contenuto tecnologico. Per un potenziamento del team siamo alla ricerca di un Commissioning Engineer. RESPONSABILITÀ La risorsa sarà responsabile delle attività di commissioning e messa in servizio degli impianti presso i...35.000 € - 45.000 €
...Commissioning a Milano, in modalità ibrida 3+2, con focus su aggiornamento programmi, monitoraggio milestone e raccolta input dai team Engineering, Construction e Commissioning. La posizione richiede laurea in Ingegneria, esperienza in planning e controllo avanzamento,...Lavoro ibrido50.000 € - 55.000 €
ppPer solida realtà industriale, LEADER INTERNAZIONALE nella progettazione, produzione e installazione di impianti per la colata e la laminazione continua di metalli non ferrosi, riconosciuta per l’elevato know-how ingegneristico, l’affidabilità tecnologica e la capacità...Impiego permanenteRemoto30.000 € - 40.000 €
...Ali Professional ricerca Commissioning engineer - Nord Italia per importante realtà internazionale leader nel settore impiantistico e del trattamento acque, attiva nella progettazione, realizzazione e gestione di impianti industriali complessi. La figura sarà inserita...Tempo pienoStage/TirocinioVitto e alloggioWeekend- pIMS Srl cerca un Commissioning Engineer per progetto di infrastruttura galleria in Iraq, con focalizzazione su Tests on Completion, Commissioning e Trial Tests. Supervisione in cantiere, verifica prove e gestione integrata di sistemi complessi della galleria. /ppLa risorsa...
35.000 € - 45.000 €
...plans , report di avanzamento e dashboard di progetto. Raccogliere, verificare e consolidare gli input provenienti dai team di Engineering, Construction, Commissioning e dalle altre funzioni di progetto. Supportare il monitoraggio delle attività di commissioning,...Lavoro ibrido- ppbFreelance Commissioning Engineer - Data Centre Project - Italy /b /p pWe are currently supporting a major bhyperscale Data Centre project in Northern Italy /b and are looking to speak with experienced Commissioning Engineers for a long-term freelance assignment. /p...Libero professionistaLungo termine
