Senior Validation Manager

The Senior Validation Manager is leading the site validation program and all qualification and validation activities at the Erytech, Princeton site, NJ.

Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment.

In this role, you will define, implement and maintain the validation program for the site, ensuring compliance to the company quality guideline, FDA regulatory requirements, and cGMP regulations.

RESPONSIBILITIES The ideal candidate will have strong understanding of risk-based approach to validation, related to aseptic process and environmental control and extended experience with risk assessment including FMEA and AMDEC.

Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality teams.

Manage multiple validation projects simultaneously, plan, coordinate an...