Validation Engineer - Life Sciences
Overview As 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.
Responsabilità
Support Commissioning, Qualification, and Validation documentation for pharmaceutical facilities, utilities, and equipment
Write and execute protocols (field verification) and develop summary reports at client sites
Manage CQV documentation lifecycle from SLIA generation to OQ completion
Support onsite and offsite activities: FATs, SATs, IOQ and PQ executions and system walkdowns
Provide cGMP leadership for CQV services delivery to Life Sciences clients
Contribute to design reviews and URS, IQ/OQ/PQ generation and execution
Troubleshoot technical issues and leverage knowledge of GMP-based processes
Collaborate with project teams and build a capable, independent project approach
Travel within Italy and internationally as required
Requisiti fondamentali
- 4–8 years' experience in commissioning/qualification in FDA-regulated industry
- Experience with facilities and equipment startup, walk downs, utilities (WFI, RO, HVAC)
- FAT/SAT, URS, P&IDs;, IQ/OQ/PQ generation and execution
- Isolation protocols, VHP cycles, and GMP knowledge is a plus
- Proficient in Microsoft Word and Excel
- Excellent written and oral English; strong problem-solving skills
- Ability to travel for onsite/offsite activities
- Strong attention to detail and ability to multi-task
- strong problem-solving and troubleshooting
- ability to work independently and build team quickly
- excellent communication in English
- CQV methodologies (FAT/SAT/IQ/OQ/PQ)
- URs, P&IDs;, design reviews
- GMP practices and cGMP leadership
Responsabilità
Support Commissioning, Qualification, and Validation documentation for pharmaceutical facilities, utilities, and equipment
Write and execute protocols (field verification) and develop summary reports at client sites
Manage CQV documentation lifecycle from SLIA generation to OQ completion
Support onsite and offsite activities: FATs, SATs, IOQ and PQ executions and system walkdowns
Provide cGMP leadership for CQV services delivery to Life Sciences clients
Contribute to design reviews and URS, IQ/OQ/PQ generation and execution
Troubleshoot technical issues and leverage knowledge of GMP-based processes
Collaborate with project teams and build a capable, independent project approach
Travel within Italy and internationally as required
Requisiti fondamentali
- 4–8 years' experience in commissioning/qualification in FDA-regulated industry
- Experience with facilities and equipment startup, walk downs, utilities (WFI, RO, HVAC)
- FAT/SAT, URS, P&IDs;, IQ/OQ/PQ generation and execution
- Isolation protocols, VHP cycles, and GMP knowledge is a plus
- Proficient in Microsoft Word and Excel
- Excellent written and oral English; strong problem-solving skills
- Ability to travel for onsite/offsite activities
- Strong attention to detail and ability to multi-task
- strong problem-solving and troubleshooting
- ability to work independently and build team quickly
- excellent communication in English
- CQV methodologies (FAT/SAT/IQ/OQ/PQ)
- URs, P&IDs;, design reviews
- GMP practices and cGMP leadership