Senior Engineer - Process Monitoring, CPV and Manufacturing Systems

BioPharma Consulting JAD Group; Juncos (PR); Presencial; USD 47.000 - 69.000; Jornada completa

Descripción de la vacante

BioPharma Consulting JAD Group seeks a manufacturing process engineering support professional in Juncos, Puerto Rico. You will lead CPV activities, configure and support manufacturing systems, and coordinate controlled document changes for drug product operations.

The role requires strong data interpretation, experience in a GxP/GMP environment, and bilingual English/Spanish communication. Administrative shifts, 7-month contract with potential extension, Monday–Friday.

Formación

• 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).

Responsabilidades

• 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.

Descripción del empleo

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