CQV Engineer: Pharma Validation & Commissioning Lead

CAI; Lombardia; Vor Ort; EUR 34.000 - 45.000; Vollzeit

Zusammenfassung

CAI is seeking a qualified CQV specialist in Italy to support commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.

You will write and execute protocols, develop summary reports at client sites, and manage the CQV documentation lifecycle from SLIA to OQ, while providing cGMP leadership for our Life Sciences clients. Travel to sites in Italy and abroad is expected.

Qualifikationen

• BS or MS in a relevant science or engineering field, or equivalent hands-on experience.
• 2/3 years' experience performing commissioning and/or qualification activities in an FDA regulated industry.
• Experience in facilities and equipment startup, walk-downs and troubleshooting, utilities (WFI, RO, HVAC), FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
• Fluent English

Aufgaben

• Support documentation for commissioning, qualification of pharmaceutical facilities, utilities, and equipment.
• Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
• Support onsite and offsite activities, such as FATs, SATs, IOQ and PQ executions and System Walkdowns.
• Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
• Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
• Excellent technical problem-solution and troubleshooting skills, with solid knowledge of typical project technical issues deadlines.
• Ability to work independently, while quickly building and nurturing a project team.

Kenntnisse

Attention to detail

Multi-tasking

Independent worker

English proficiency

Ausbildung

BS or MS in relevant science or engineering

Tools

Microsoft Word

Microsoft Excel

Jobbeschreibung

CAI is seeking a qualified CQV specialist in Italy to support commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.

You will write and execute protocols, develop summary reports at client sites, and manage the CQV documentation lifecycle from SLIA to OQ, while providing cGMP leadership for our Life Sciences clients. Travel to sites in Italy and abroad is expected.