CQV Engineer

We are looking for a CQV Engineer to join our growing Operation team in Italy. The CQV Engineer is responsible for documentation related to Commissioning, Qualifications, and Validation.

Requirements

• High attention to detail
• Ability to multitask and take initiative to complete assigned tasks with precision, according to established timelines
• Bachelor's or Master's degree in a relevant scientific or engineering field, or equivalent years of practical experience
• At least 4-8 years of experience in executing commissioning and/or qualification activities in a regulated industry by FDA/AIFA

Benefits

• Desirable Skills: Already experienced startup of facilities/equipment, inspections, and problem-solving, facilities (WFI, RO, HVAC), building automation, or other pharmaceutical production processes and equipment, FAT/SAT, URS, P&ID, IQ/OQ/PQ, generation and execution, etc.
• Leadership and guidance for the integration and delivery of CQV services to our Life Sciences clients
• Excellent problem-solving and technical troubleshooting skills, with a solid understanding of typical project technical issues
• Ability to work independently, collaborating with project teams
• Manage the lifecycle of C&Q documentation and execution, from SLIA generation to OQ completion
• Support onsite activities (both at client and vendor sites), such as: FAT, SAT, IOQ execution and PQ, and system walkdowns
• Experience in production processes in the Life Sciences sector in areas such as biotechnology, aseptic processing, aseptic filling and finishing, OSD, gene therapy, or equivalent experience
• Familiarity with the Baseline Guide 5 (Second Edition) will be considered a plus
• Other Requirements: Required skills: execution and reporting of qualification protocols for isolators, development of VHP cycles, GMP-based knowledge
• Proficiency in Microsoft Word and Excel
• Excellent spoken and written English language skills