Senior Engineer - Process Monitoring, CPV and… at BioPharma… · Juncos

Senior Engineer - Process Monitoring, CPV and Manufacturing Systems

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.

Requirements

• 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).

Benefits

• Contract: 7 months, with possible extension
• Shift: Administrative, Monday–Friday