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.

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