Senior Manufacturing Engineer - Process Validation & PM

FITS LLC; Caguas (PR); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

FITS LLC is a service provider delivering Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island and in the US. We seek a Manufacturing Engineering Project Manager who can lead complex projects, apply DMAIC/A3, and ensure quality, safety and timely implementations across partnerships with pharmaceutical and manufacturing clients.

You will collaborate with cross-functional teams, document protocols, and drive process validations while upholding our

Formación

• Bachelor’s Degree and minimum five years of experience in regulated industries.
• Shift: Administrative & according to business needs.
• Experience in Manufacturing Engineering & Technical Project Management; Process Validation, Qualification & Statistical Data Analysis; Root Cause Analysis, Troubleshooting & Continuous Improvement (DMAIC/A3)

Responsabilidades

• Lead moderately to highly complex projects with little to no supervision.
• Manage project resources, budgets and planning.
• Define resources, performance reviews and post-implementation evaluations.
• Take ownership of successful project implementation.
• Lead cross-functional teams to support NPI methodology.
• Document activities in a timely manner per business standards.
• Run validation studies on the line and write protocols/reports with minimal oversight.
• Provide guidance for validation deviations and complex data analysis.
• Lead root cause analysis for high complexity manufacturing events.

Conocimientos

Project management

DMAIC

Root cause analysis

Statistical data analysis

Process validation

Quality systems

Budgeting

Bilingual SP-EN

Manufacturing engineering

Educación

Bachelor’s Degree

Herramientas

Minitab

Excel

JMP

Descripción del empleo

FITS LLC is a service provider delivering Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island and in the US. We seek a Manufacturing Engineering Project Manager who can lead complex projects, apply DMAIC/A3, and ensure quality, safety and timely implementations across partnerships with pharmaceutical and manufacturing clients.

You will collaborate with cross-functional teams, document protocols, and drive process validations while upholding our