Senior Engineer - Process Monitoring, CPV and Manufacturing Systems
BioPharma Consulting JAD GroupThis role supports manufacturing process engineering, system configuration, and continuous process verification for drug product operations. Responsibilities include leading CPV activities, configuring manufacturing systems, managing change controls, and analyzing data for troubleshooting and continuous improvement. Candidates must possess a relevant bachelor's degree with four years of experience or a master's degree with two years of experience in a GxP environment.
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
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