About this role
Support manufacturing process engineering, system configuration and continuous process verification for drug product operations at a leading biotechnology company in Juncos, Puerto Rico. What you'll do Lead CPV activities: process data review, trend identification, periodic reports and escalation of performance issues. Configure and support manufacturing systems (DME, PLM, MMP/MPP management): gather requirements, implement and test changes, and document results.
Coordinate controlled document and process changes through review, approval and implementation. Interpret manufacturing data to support investigations, troubleshooting and continuous improvement. Use digital tools to improve reporting, monitoring and workflows.
Bachelor's in Engineering + 4 years (or Master's + 2, or Doctorate); Chemical, Mechanical, Electrical, Industrial, Biomedical or related. Manufacturing support in a GxP/GMP environment. Change control, controlled documentation and data integrity. Strong Excel; JMP and/or Power BI. SQL, Smartsheet, Power Query or Power Automate (a plus). Fully bilingual (English/Spanish).
Contract: 7 months, with possible extension Shift: Administrative, Monday–Friday