Senior Commissioning and Qualifications Engineer

2 settimane fa


Milano, Lombardia, Italia Cai A tempo pieno
Commissioning, Qualification, and Validation Engineer

At Cai, we are seeking a skilled Commissioning, Qualification, and Validation (CQV) Engineer to support the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.

Main Responsibilities:
  • Develop documentation to support Commissioning, Qualification, and Validation activities
  • Responsible for protocol writing and execution, field verification, and development of summary reports at client sites
  • Support onsite and offsite activities, such as FATs, SATs, IOQ and PQ Executions and System Walkdowns

Requirements:

  • High attention to detail
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately
  • Minimum 4 – 8 years' experience performing commissioning and / or qualification activities in an FDA regulated industry
  • Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience

Preferred Skills:

  • Expertise in Microsoft Word and Excel
  • Familiarity with Baseline Guide 5 (Second Edition)

What We Offer:

  • Excellent technical problem-solving and troubleshooting skills
  • Leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients

About Us:

Cai is a leading provider of CQV services for the Life Sciences industry. We pride ourselves on our commitment to delivering high-quality services and solutions to our clients. We are looking for talented individuals who share our passion for excellence and are dedicated to making a difference in the industry.



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