Location : Milano area, IT
Start Date : Immediate need
Duration : ~ 6 months (high possible extension)
Title : Project Engineer - Sterile Manufacturing
Description: 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 background
* Sterile manufacturing expertise
* Min. 5 years’ experience as project engineer
* English & Italian speaker