Process Development Engineer

Full Time Contract Title: Process Development Engineer Location: Dorado, Puerto Rico Length of Contract: 12 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.

+ Automation & Tooling: Collaborate on the design and integration of automated systems, including vision inspection, PLC-control...