RCM Life Sciences and IT
Dorado, Puerto Rico, United States
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 "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...
