Process Development Engineer

Full Time Contract Title or Role: Process Development Engineer Location: Onsite - Dorado PR Length of Contract: 6 to 12 months Position Description: The Process Development Engineer plays a critical role in developing, documenting, and validating manufacturing processes and automated systems. This position supports both Process Development and Manufacturing Engineering initiatives to ensure patient safety, product quality, and compliance with our client Quality Policy. Responsibilities:

+ Lead Validation Documentation: Develop, review, and execute process validation protocols and reports (IQ, OQ, PQ) for new processes or equipment.

+ Support New Process Qualification: Work closely with the Process Development team to efficiently qualify new processes , including assistance with statistical sampling plans and design of experiments (DOE).

+ Risk Analysis & Mitigation: Understand, evaluate, and develop solutions to minimize risks associated with manufactur...