Validation Engineer
bOverview /b pAs a CQV Engineer at CAI, you drive commissioning, qualification, and validation activities for pharmaceutical facilities and equipment in Italy. You will develop protocols, perform field verifications, and prepare summary reports at client sites, ensuring cGMP compliance. You’ll support end-to-end CQV documentation lifecycle and collaborate with cross-functional teams to deliver reliable, compliant systems. This role offers hands-on site work, travel opportunities, and a direct impact on project readiness in life sciences environments. /p bResponsabilità /bulliSupport Commissioning, Qualification, and Validation documentation for pharmaceutical facilities, utilities, and equipment /liliWrite and execute protocols (field verification) and develop summary reports at client sites /liliManage CQV documentation lifecycle from SLIA generation to OQ completion /liliSupport onsite and offsite activities: FATs, SATs, IOQ and PQ executions and system walkdowns /liliProvide cGMP leadership for CQV services delivery to Life Sciences clients /liliContribute to design reviews and URS,
IQ/OQ/PQ generation and execution /liliTroubleshoot technical issues and leverage knowledge of GMP-based processes /liliCollaborate with project teams and build a capable, independent project approach /liliTravel within Italy and internationally as required /li /ul bRequisiti fondamentali /bulli4–8 years’ experience in commissioning/qualification in FDA-regulated industry /liliExperience with facilities and equipment startup, walk downs, utilities (WFI, RO, HVAC) /liliFAT/SAT, URS, PIDs, IQ/OQ/PQ generation and execution /liliIsolation protocols, VHP cycles, and GMP knowledge is a plus /liliProficient in Microsoft Word and Excel /liliExcellent written and oral English; strong problem-solving skills /liliAbility to travel for onsite/offsite activities /liliStrong attention to detail and ability to multi-task /li /ulullistrong problem-solving and troubleshooting /liliability to work independently and build team quickly /liliexcellent communication in English /liliCQV methodologies (FAT/SAT/IQ/OQ/PQ) /liliURs, PIDs, design reviews /liliGMP practices and cGMP leadership /li /ul
IQ/OQ/PQ generation and execution /liliTroubleshoot technical issues and leverage knowledge of GMP-based processes /liliCollaborate with project teams and build a capable, independent project approach /liliTravel within Italy and internationally as required /li /ul bRequisiti fondamentali /bulli4–8 years’ experience in commissioning/qualification in FDA-regulated industry /liliExperience with facilities and equipment startup, walk downs, utilities (WFI, RO, HVAC) /liliFAT/SAT, URS, PIDs, IQ/OQ/PQ generation and execution /liliIsolation protocols, VHP cycles, and GMP knowledge is a plus /liliProficient in Microsoft Word and Excel /liliExcellent written and oral English; strong problem-solving skills /liliAbility to travel for onsite/offsite activities /liliStrong attention to detail and ability to multi-task /li /ulullistrong problem-solving and troubleshooting /liliability to work independently and build team quickly /liliexcellent communication in English /liliCQV methodologies (FAT/SAT/IQ/OQ/PQ) /liliURs, PIDs, design reviews /liliGMP practices and cGMP leadership /li /ul