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CAI
CAI
501 – 1.000 Angajați
Sponsor pentru viza H1BAsistență medicalăConsultanțăIndustria prelucrătoare
CAI oferă servicii de inginerie și consultanță organizațiilor care activează în medii reglementate și complexe din punct de vedere tehnic. Activitatea companiei include punerea în funcțiune și calificarea, punerea în funcțiune a clădirilor, gestionarea activelor, calitatea și conformitatea, transformarea digitală și automatizarea. CAI deservește proiecte din biotehnologie, industria farmaceutică, sănătate, producție și centre de date, ajutând echipele să pregătească instalațiile și operațiunile pentru o utilizare fiabilă și conformă. Proiectele globale ale CAI acoperă întregul parcurs, de la livrarea instalațiilor până la pregătirea operațională.
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Locurile de muncă ale companiei

Validation Engineer, Pharmaceutical CQV

Develop and execute commissioning, qualification, and validation documentation for pharmaceutical facilities, utilities, and equipment. Support CAI’s life sciences clients through onsite and offsite CQV work.

ITItalia
45.800 € – 57.000 € / an
HibridNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăInginer

Descriere

  • Create documentation for commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.
  • Write and execute protocols, including field verification.
  • Prepare summary reports at client sites.
  • Provide cGMP leadership and guidance for CQV service integration and delivery.
  • Manage the C&Q documentation and execution lifecycle, from SLIA generation through OQ completion.
  • Support onsite and offsite work, including FATs, SATs, IOQ and PQ executions, and system walkdowns.
  • Contribute to client projects at CAI, which serves the life sciences and mission critical industries.

Cerințe

  • Hold European citizenship or a valid residence permit for Europe.
  • Have a bachelor’s or master’s degree in a relevant science or engineering discipline, or equivalent hands-on experience.
  • Bring at least 4–8 years of commissioning and/or qualification experience in an FDA-regulated industry.
  • Have experience with facility and equipment startup, walkdowns and troubleshooting, utilities (WFI, RO, HVAC), building automation, pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design reviews, P&IDs, and IQ/OQ/PQs.
  • Demonstrate strong attention to detail.
  • Be able to manage multiple tasks and take initiative.
  • Know how to provide cGMP leadership and guidance.
  • Have strong technical problem-solving and troubleshooting skills.
  • Work independently and build a project team.
  • Be proficient in life science manufacturing processes such as biotech, aseptic processing, aseptic fill/finish, OSD, or gene therapy.
  • Familiarity with Baseline Guide 5 (Second Edition) is a plus.
  • Have experience executing and reporting isolator qualification protocols, developing VHP cycles, and applying GMP knowledge.
  • Be proficient with Microsoft Word and Excel.
  • Have excellent spoken and written English.
  • Be available to travel within Italy and internationally.

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Ohio State University Physicians

Remote Financial Clearance Representative L3 (Financial Counselor)

Ohio State University Physicians
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Asigurare de sănătateAsistență medicalăNonprofit
USStatele Unite ale AmericiiOHOhio
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RemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăConsilier

Verify patient coverage, eligibility, and financial responsibility as a financial counselor with Ohio State University Physicians. Help uninsured patients access financial assistance and coordinate clearance for scheduling.

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