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CAI

Validation Engineer

CAI

. Develop documentation supporting Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment .

Posted 10/12/2026full-timeMilan • ItalyMid-LevelSenior💰 €45,800 - €57,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Commissioning, Qualification, and Validation processes within FDA-regulated environments, with a strong focus on cGMP compliance and life science manufacturing. Proficient in developing documentation, executing protocols, and providing leadership in CQV service integration.

Highest-signal resume keywords
Commissioning And Qualification ActivitiesCGMP Leadership And GuidanceLife Science Manufacturing ProcessesTechnical Problem-Solving SkillsMicrosoft Word And Excel Proficiency

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
CommissioningQualificationValidationProtocol DevelopmentField VerificationUtilities ManagementPharmaceutical Manufacturing ProcessesIsolators Qualification ProtocolsVHP Cycle DevelopmentTroubleshooting
Soft Skills
Attention To DetailMultitaskingInitiativeIndependent WorkTeam Building
Tools & Technologies
Building AutomationFAT/SATP&IDsIQ/OQ/PQBaseline Guide 5
Industry Keywords
CGMPFDA-Regulated IndustryLife SciencesMission Critical IndustriesAseptic ProcessingGene Therapy

About the role

Key responsibilities & impact
  • Develop documentation supporting Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment
  • Write and execute protocols, including field verification
  • Develop 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 activities including FATs, SATs, IOQ and PQ executions, and system walkdowns
  • Support client projects for CAI, a professional services company serving Life Sciences and Mission Critical industries

Requirements

What you’ll need
  • European citizenship or a valid residence permit for Europe
  • 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
  • Experience with facilities and equipment startup, walk downs and troubleshooting, utilities (WFI, RO, HVAC), building automation, pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, and IQ/OQ/PQs
  • High attention to detail
  • Ability to multitask and take initiative
  • cGMP leadership and guidance knowledge
  • Excellent technical problem-solving and troubleshooting skills
  • Ability to work independently and build a project team
  • Proficiency 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
  • Isolators qualification protocols execution and reporting, VHP cycle development, and GMP-based knowledge
  • Expertise in Microsoft Word and Excel
  • Excellent oral and written English
  • Availability to travel in Italy and abroad