CQV Engineer Staff II

Position Description:

We are now seeking a CQV Engineer to join our growing operations in Italy. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.

The role of a CQV Engineer in CAI is to:

Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.

Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. 

Position Requirements:

High attention to detail

Ability to multi-task and take initiative to accomplish assigned tasks accurately by 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 / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.

Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.

Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues

deadlines

Ability to work independently, while quickly building and nurturing a project team

Managing the C&Q documentation and execution lifecycle from  SLIA generation through to OQ completion.

Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns

Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.

Familiarity with Baseline Guide 5 (Second Edition) a plus

Expected skills: Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge

Expertise in Microsoft Word and Excel

Excellent oral and written English are required.

Available for travel in Italy and abroad.