Project Engineer Bardi

Project Engineer
Bardi
Emilia Romagna, Bardi

Location: Milano area, ITStart Date: Immediate needDuration: ~ 6 months (high possible extension)Title: Project Engineer - Sterile ManufacturingDescription: The client is seeking an experienced project engineer to support the start-up of a new sterile filling production line.

The fill-finish line will include isolators, autoclaves, washers, clean utilities, etc.

and setting up a Grade C area within the facility.

The client is currently in the design phase for the facilities and utilities and will need the consultant to provide project engineering, technical expertise/guidance, problem-solving/trouble-shooting with the aseptic areas and coordinating/collaborating with internal team and vendors. Collaborate closely with the project team and external vendors to oversee the design, engineering, and installation of the new sterile production line. Provide technical expertise and support for all aspects of the project (including: Autoclave qualification, washer qualification, compounding area design, C-grade area qualification)Support the development and execution of validation protocols for the new production line. Ensure adherence to Good Manufacturing Practices (GMP) and all relevant regulatory requirements throughout the project lifecycle. Contribute to the development of standard operating procedures (SOPs) for the new production line. Troubleshoot technical challenges and resolve any issues that may arise during the project. Maintain accurate and up-to-date project documentation. Liaise with internal stakeholders (e. g. , engineering, quality control, production) to ensure smooth project execution. Skills:Engineering backgroundSterile manufacturing expertiseMin.

5 years' experience as project engineerEnglish & Italian speaker