Job Overview
The Process Validation Associate plays a pivotal role in ensuring the quality and integrity of manufacturing systems and processes.
* Responsibilities include conducting process validation activities for drug substance and drug products throughout clinical and commercial stages.
* Process validation specialists will also execute activities related to the implementation of process changes and new processes.
* Additionally, they will assist with regulatory filings and respond to questions from regulatory agencies.
Requirements:
* Bachelor's degree in a technical discipline such as physical, engineering, chemical or biological sciences is required.
* At least 2 years of experience in a cGMP regulated manufacturing environment is necessary.
* Excellent organizational and management skills are essential.
* Able to communicate effectively with various hierarchical audiences.