Cqv Engineer Bologna
BolognaEurope Life Sciences – South Europe / Full Time / Hybrid
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 individuals are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
Responsibilities: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.
Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
Manage 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.
Position Requirements: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.
Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation, or other pharmaceutical manufacturing processes and equipment.
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) is a plus.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
High attention to detail.
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
Ability to work independently while quickly building and nurturing a project team.
Other Requirements:Expertise in Microsoft Word and Excel.
Excellent oral and written English are required.
Available for travel in Italy and abroad.
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