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CAI
CAI
501 – 1,000 Employees
H1B Visa SponsorConsultingHealthcareManufacturing
CAI provides engineering and consulting services for organizations working in regulated and technically complex environments. Its work includes commissioning and qualification, building commissioning, asset management, quality and compliance, digital transformation, and automation. The company serves biotechnology, pharmaceutical, healthcare, manufacturing, and data center projects, helping teams prepare facilities and operations for reliable, compliant use. CAI’s global project work spans facility delivery through operational readiness.
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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.

ITItaly
€45,800 – €57,000 / year
HybridFull-timeMiddleSeniorEnglish RequiredEngineer

Description

  • 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.

Requirements

  • 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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