ph3Responsibilities /h3 ul liDevelop the documentation to support Commissioning, Qualifications, and Validation.
/li liResponsible for protocol writing and execution, field verification, and development of summary reports at client sites.
/li liSupport documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
/li /ul h3Requirements /h3 ul liHigh attention to detail.
/li liAbility to multi-task and take initiative to accomplish assigned tasks accurately.
/li liEstablished BS or MS in a relevant science or engineering field, or equivalent years of hands?on experience.
/li liMinimum 2–3 years' experience performing commissioning and/or qualification activities in an FDA regulated industry.
/li liExperience in facilities and equipment startup, walkdowns troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, PIDs, IQ/OQ/PQs, generation execution, etc.
/li liProvide cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients.




/li liExcellent technical problem?solving and troubleshooting skills, with solid knowledge of typical project technical issues.
/li liAbility to work independently, while quickly building and nurturing a project team.
/li liManaging the CQ documentation and execution lifecycle from SLIA generation through to OQ completion.
/li liSupport onsite and offsite activities such as FATs, SATs, IOQ and PQ executions and system walkdowns.
/li liProficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
/li liFamiliarity with Baseline Guide 5 (Second Edition) is a plus.
/li liExpected skills: Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge.
/li liExpertise in Microsoft Word and Excel.
/li liExcellent oral and written English is required.
/li liAvailable for travel in Italy and abroad.
/li /ul /p #J-*****-Ljbffr

📌 Cqv Engineer (Milano)
🏢 Jobtailor
📍 Milano