Velidation Expert

Descrizione dell'offerta

Validation Expert - 12M Temporary Contract

Main Requirements:

·  Graduate in Mechanical or Chemical Engineering to fill the role of Validation Expert within the identified area of application
·  The candidate must be able to work in team and have a good technical background, together with coordination abilities, communication skills and strong flexibilities, with a good knowledge of English
·  To work in close cooperation with experienced Validation Team to support them in all aspect of Qualification of Pharma Equipments
·  Availability to national and international mission if required

Main tasks:

·  Support Validation Experts in managing Pharma Projects on
·  New Equipment and Control System
·  Utilities Upgrade or Enlargement
·  New manufacturing workshop or existing one refurbishment and improvement
·  Perform process activities related to Process Units of Pharmaceutical / Bio-Pharma Industry including development of Validation Protocols and Reports.
·  Capability to review the equipment technical documentations in order to assure the compliance versus international GMP regulations as Block Flow Diagram, of Process Flow Diagram, , P&ID’s, data sheets of equipment, Technical Specification/URS
·  Capability of to perform validation activities, interfacing with other site figures as Production, Maintenance and Engineering departments.

What you will learn:

·  Knowledge of main Pharma equipments and related Key operation aspects
·  Knowledge of Pharma projects managements starting from design until release in production
·  Expertize in regulatory cGMP environment, knowledge of GAMP for the Injectable Products Fill and Finish Manufacturing steps
·  Knowledge and capability about Qualification Activities
·  Knowledge of documentation for qualification and validation: URS, FAT, SAT, DQ, MT, IQ, OQ, PQ
·  Execution in field of tests required for the qualification of equipment

Opportunities:

·  Training on the job with experienced supervision
·  Experience and knowledge as Validation Engineer in Pharma environment
·  Knowledge of Manufacturing Process for High Regulated Market supply (EMEA, Japan, US)
·  Interdisciplinary communication and synergic conjunction with other Technical Department like Maintenance, Utilities, Quality and Engineering
·  Be involved in increasingly complex and strategic projects

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.