Senior Engineer, GMP Manufacturing & CPV Excellence

Mirus Consulting Group; Juncos (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Sr. Engineer to support manufacturing operations in a regulated GMP/GxP environment. You will assist process reliability, CPV activities, and CAPA implementation to ensure compliant, efficient operations.

You will collaborate with cross-functional teams to monitor performance, analyze data, and maintain controlled documentation while supporting continuous improvement initiatives.

Qualifications

• Bachelor's degree in Engineering preferred; Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field.
• Experience supporting manufacturing operations in a regulated GxP/GMP environment is desirable.
• Knowledge of manufacturing processes, equipment, devices, packaging, and operations is a strong plus.

Responsabilités

• Support day-to-day manufacturing operations to ensure process reliability, compliance, and operational efficiency.
• Monitor processes, equipment, and systems to identify performance trends and opportunities for improvement.
• Support CPV activities, including data analysis, trend identification, report generation, and presentations.
• Participate in investigations, root cause analysis, and CAPA implementation.
• Support system configuration, changes, testing, documentation, and troubleshooting.
• Manage changes through Change Control and coordinate controlled document updates.

Connaissances

GxP/GMP experience

CPV data analysis

Process monitoring

Change control

Document management

SQL

Power BI

Excel

JMP

Smartsheet

Microsoft 365

Formation

Bachelor’s degree in Engineering

Outils

DME

PLM

Power BI

SQL

JMP

Smartsheet

Description du poste

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Sr. Engineer to support manufacturing operations in a regulated GMP/GxP environment. You will assist process reliability, CPV activities, and CAPA implementation to ensure compliant, efficient operations.

You will collaborate with cross-functional teams to monitor performance, analyze data, and maintain controlled documentation while supporting continuous improvement initiatives.