CQV Engineer

6 giorni fa

Milano, Lombardia, Italia Cai A tempo pieno
About the Role

We are seeking a highly skilled CQV Engineer to join our team at Cai, a leading provider of life sciences services. As a CQV Engineer, you will play a critical role in supporting the commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.

Key Responsibilities
  • Develop and execute commissioning and qualification protocols for pharmaceutical facilities, utilities, and equipment.
  • Conduct field verifications and develop summary reports for client sites.
  • Support the development of technical documentation, including protocols, reports, and other related documents.
  • Collaborate with cross-functional teams to ensure seamless execution of CQV projects.
  • Provide technical leadership and guidance to project teams on CQV-related matters.
Requirements
  • Bachelor's or Master's degree in a relevant science or engineering field, or equivalent years of hands-on experience.
  • Minimum 4-8 years of experience in commissioning and qualification activities in an FDA-regulated industry.
  • Proven expertise in facilities and equipment startup, walk-downs, and troubleshooting.
  • Strong knowledge of pharmaceutical manufacturing processes, including biotech, aseptic processing, and OSD.
  • Excellent technical problem-solving and troubleshooting skills.
  • Ability to work independently and lead project teams.
  • Proficient in Microsoft Word and Excel.
Preferred Qualifications
  • Familiarity with Baseline Guide 5 (Second Edition).
  • Experience with isolators qualification protocols, VHP cycle development, and GMP-based knowledge.
About Cai

Cai is a leading provider of life sciences services, dedicated to delivering high-quality solutions to our clients. We are committed to excellence and innovation, and we are seeking talented individuals to join our team.

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