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 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 (field verification) and development of summary reports at client sites.
Position Requirements:
BS or MS in a relevant science or engineering field or equivalent years of handson 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 & etc.
Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
Excellent technical problemsolving and troubleshooting skills with solid knowledge of typical project technical issues
High attention to detail
Ability to multitask and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently while quickly building and nurturing a project team
Managing the C&Q documentation and lifecycle fromSLIA 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
Other Requirements:
Expertise in Microsoft Word and Excel
Excellent oral and written English are required.
Suitable candidates must be available for travel throughout Italy and some European travel may be required.
La selezione rispetta il principio delle pari opportunit (l. 903/77
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