CQV Engineer
OverviewAs a CQV Engineer in Italy, you will develop and execute documentation for commissioning, qualification, and validation of facilities, utilities, and equipment. You will write protocols, perform field verifications, and craft summary reports at client sites, supporting cGMP-compliant CQV services. You’ll lead the CQV documentation lifecycle from SLIA generation to OQ completion and collaborate with cross-functional teams to deliver validated systems. This role offers hands-on problem solving in a regulated life sciences environment with global travel. You will help ensure reliable, compliant startup and operation of critical manufacturing assets.
Responsabilità
Support CQV documentation for commissioning, qualification, and validation activitiesWrite and execute protocols and perform field verificationsDevelop summary reports at client sitesManage CQV lifecycle from SLIA generation to OQ completionSupport on-site and off-site activities including FATs, SATs, IOQ and PQ executions and system walkdownsProvide cGMP leadership for CQV services deliveryWork with life sciences processes and equipment startup, walkdowns,
and troubleshootingAssist with design reviews, URS, P&IDs;, and IQ/OQ/PQ documentation and execution
Requisiti fondamentali
BS or MS in a relevant science or engineering field, or equivalent experience4–8 years’ experience in commissioning/qualification in an FDA-regulated industryExperience with facilities and equipment startup, walkdowns, utilities (WFI, RO, HVAC), FAT/SAT, URS, design review, P&IDs;, IQ/OQ/PQsProficient in life science manufacturing processes (biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy)Baseline Guide 5 (Second Edition) familiarity is a plusIsolators qualification protocols execution and reporting, VHP cycle development, GMP knowledge (preferred)Excellent MS Word and Excel skillsStrong English (oral and written)Willingness to travel within Italy and abroadstrong problem-solving skillsexcellent written and verbal communicationability to work independently and build a project teamCQV documentation and protocol writingfield verification and system walkdownsFAT/SAT/IOQ/PQ execution
Responsabilità
Support CQV documentation for commissioning, qualification, and validation activitiesWrite and execute protocols and perform field verificationsDevelop summary reports at client sitesManage CQV lifecycle from SLIA generation to OQ completionSupport on-site and off-site activities including FATs, SATs, IOQ and PQ executions and system walkdownsProvide cGMP leadership for CQV services deliveryWork with life sciences processes and equipment startup, walkdowns,
and troubleshootingAssist with design reviews, URS, P&IDs;, and IQ/OQ/PQ documentation and execution
Requisiti fondamentali
BS or MS in a relevant science or engineering field, or equivalent experience4–8 years’ experience in commissioning/qualification in an FDA-regulated industryExperience with facilities and equipment startup, walkdowns, utilities (WFI, RO, HVAC), FAT/SAT, URS, design review, P&IDs;, IQ/OQ/PQsProficient in life science manufacturing processes (biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy)Baseline Guide 5 (Second Edition) familiarity is a plusIsolators qualification protocols execution and reporting, VHP cycle development, GMP knowledge (preferred)Excellent MS Word and Excel skillsStrong English (oral and written)Willingness to travel within Italy and abroadstrong problem-solving skillsexcellent written and verbal communicationability to work independently and build a project teamCQV documentation and protocol writingfield verification and system walkdownsFAT/SAT/IOQ/PQ execution