Process Development Engineer

Full Time Contract

Title: Process Development Engineer
Location: Dorado, Puerto Rico
Length of Contract: months with potential to extend

Position Description:

As a Contract Process Development Engineer will bridge the gap between initial design and full-scale manufacturing. You will handle the characterization, validation, and optimization of complex automated processes. This role requires a hands-on technical expert who thrives in an FDA-regulated environment and can navigate the rigors of IQ/OQ/PQ with precision.

Responsibilities

Validation Leadership: Lead the execution of IQ/OQ/PQ protocols; author comprehensive Master Validation Plans (MVP) and summary reports.

Process Characterization: Utilize Design of Experiments (DOE) and PFMEA to establish robust process windows and mitigate manufacturing risks.