Cqv Documentation Specialist

3 settimane fa


Milano, Lombardia, Italia Cai A tempo pieno
CQV Engineer Role

At Cai, we're seeking a skilled CQV Engineer to support the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. The ideal candidate will have a strong background in FDA-regulated industries and a proven track record of successful commissioning and qualification activities. Key responsibilities include developing documentation, writing and executing protocols, and conducting field verifications. Additionally, the CQV Engineer will be responsible for generating and executing qualification protocols, providing technical guidance, and ensuring compliance with cGMP regulations.

Requirements
  • High attention to detail
  • Ability to multi-task and take initiative
  • Established 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 qualification activities in an FDA-regulated industry

Preferred Skills
  • Expertise in Microsoft Word and Excel
  • Knowledge of Baseline Guide 5 (Second Edition)
  • Familiarity with life science manufacturing processes

Additional Requirements
  • Excellent technical problem-solving and troubleshooting skills
  • Ability to work independently and build a project team
  • Proficient in aseptic processing, aseptic fill/finish, OSD, Gene Therapy, or equivalent experience

Travel Requirements
The selected candidate will be available for travel in Italy and abroad.
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