CSV Engineer

Main Responsibilities:

• Management and coordination of Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical plants and equipment
• Drafting and review of technical documentation (protocol, report, SOP, URS, DQ, IQ, OQ, PQ)
• Support for the execution of tests and checks in the field
• Collaboration with quality, production, and engineering teams
• Ensuring compliance with GMP and regulatory standards
• Monitoring and resolution of deviations and non-conformities
• Participation in regulatory audits and inspections

Requirements:

• Degree in scientific disciplines (Chemistry, Biology, Pharmacy, Biotechnology, Engineering)
• Previous experience in CQV activities in the pharmaceutical/biotech sector
• Knowledge of GMP regulations and validation guidelines
• Good documentation drafting and data analysis skills
• Excellent teamwork and communication skills
• Knowledge of the English language (written and spoken)

Contractual Conditions:

• Permanent contract, based on experience
• Remuneration commensurate with skills
• Opportunity for continuous training and professional growth
• Availability to work shifts and, if necessary, during weekends
• Work location: Milan / Monza