Project Engineer: Manufacturing Efficiency & Validation

fitspr; Humacao (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS is a service provider serving the Pharmaceutical, Medical Device and Manufacturing industries. We seek a Project Engineer to drive manufacturing improvements in our Engineering area, focusing on cost reduction, process optimization, and cross-functional project delivery in a regulated environment.

Key activities include developing and implementing process improvements, validating changes (IQ/OQ/PQ), authoring technical documentation, and coordinating with equipment, materials, and packaging

Qualifications

• Bachelor's degree in engineering with 5+ years in manufacturing or process/project engineering.
• Bilingual in Spanish and English with good communication.
• Experience in manufacturing process improvements and cost reduction.
• Experience with validation/qualification activities (IQ/OQ/PQ, Process Validation).
• Experience in technical documentation, procedures, and work instructions.
• Strong root cause investigations, risk assessments, and problem solving.
• Project management and cross-functional team coordination.

Responsibilities

• Identify and execute cost reduction and manufacturing efficiency projects.
• Develop and implement process improvements and new manufacturing methods.
• Author and revise procedures, specifications, work instructions, and technical documentation.
• Support equipment, process, material, and packaging changes.
• Develop and execute validation and qualification activities (IQ/OQ/PQ, process validations, engineering studies).
• Conduct technical assessments, risk analyses, and root cause investigations.
• Coordinate cross-functional project teams to ensure timely project execution.

Skills

Bilingual Spanish-English

Project management

Cross-functional coordination

Root cause analysis

Process optimization

Education

Bachelor's Degree in Engineering

Tools

IQ/OQ/PQ Validation

Documentation methods

Job description

FITS is a service provider serving the Pharmaceutical, Medical Device and Manufacturing industries. We seek a Project Engineer to drive manufacturing improvements in our Engineering area, focusing on cost reduction, process optimization, and cross-functional project delivery in a regulated environment.

Key activities include developing and implementing process improvements, validating changes (IQ/OQ/PQ), authoring technical documentation, and coordinating with equipment, materials, and packaging