VALIDATION SPECIALIST MILAN AND LATINA

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7mv1st

CSV Life Science Group, an international engineering company, market leader in the pharmaceutical sector, is looking for a Validation Specialist to join its CQV team in Milan and Latina offices.
The resource will be placed on a permanent contract. Grade level and salary will be commensurate with experience.

REQUIRED ACTIVITY
We are looking for a Validation Specialist for our Milan and Latina offices. The resource will join the CQV team and will be involved in structured projects for major players in the pharmaceutical industry. The resource will be responsible for drafting and executing qualification protocols in the field in accordance with predefined standards and ensuring compliance with relevant regulations. Specifically, she/he will perform the following activities:
- Drafting, verification and execution of qualification protocols (DQ, IQ, OQ, PQ) for equipment, for equipment, facilities, and controlled contamination environments.
- Performing thermal mapping studies for temperature/humidity-controlled environments and equipment.

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Instrument calibration and verification activities.
- Drafting and review of technical documentation: URS, VMP, Risk Assessment, GAP Analysis, P&ID.;
- Qualification of HVAC systems, utilities (PW, WFI, Clean Steam), and process systems (RABS, isolators, autoclaves, freeze dryers).

Activities will include interfacing with customers and suppliers, meeting and coordinating with multi-disciplinary project teams.

REQUIRED CHARACTERISTICS
The ideal candidate:
- Has a Bachelor’s or Master’s degree in a scientific discipline (engineering, chemistry, CTF or related).
- Is familiar with the relevant regulations (EU GMP, FDA, Annex 11, GAMP5).
- Has at least 3 years‘ experience in a similar role within the chemical-pharmaceutical sector.
- Has a good knowledge of English (both written and spoken).
- Has expertise in the validation of plants, equipment and processes in the chemical-pharmaceutical sector.
- He is familiar with the use of the

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7mv1st