Manufacturing Process Engineer & Project Lead

FITS LLC; Humacao (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC in Humacao, PR seeks a Project Engineer to drive process improvements and cost reduction in manufacturing. The role requires a 5+ year background in regulated industries, strong bilingual Spanish/English communication, and experience with IQ/OQ/PQ and process validation.

The candidate will lead cross-functional teams, author technical docs, and coordinate projects across manufacturing, packaging, and equipment changes, aligning with quality and regulatory standards.

Qualifications

• Bachelor's degree in engineering with at least five years in manufacturing, process or project engineering or continuous improvement in regulated industries.
• Bilingual in Spanish and English with good communication.
• Shift: Administrative and according to business needs.
• Experience in manufacturing process improvements, cost reduction, validation and qualification activities (IQ/OQ/PQ).
• Technical documentation, procedures, work instructions, risk analyses and root cause investigations.

Responsibilities

• Identifying and executing cost reduction and manufacturing efficiency projects.
• Developing and implementing process improvements and new manufacturing methods.
• Authoring and revising procedures, specifications, work instructions, and technical documentation.
• Supporting equipment, process, material, and packaging changes.
• Developing and executing validation and qualification activities (IQ/OQ/PQ, process validations, engineering studies).
• Conducting risk analyses and root cause investigations.
• Coordinating cross-functional project teams to ensure timely project execution.

Skills

Manufacturing process improvements

Cost reduction initiatives

Root cause investigations

Risk assessments

Problem solving

Project management

Cross-functional teamwork

Bilingual Spanish/English

Education

Bachelor's Degree in Engineering

Job description

FITS LLC in Humacao, PR seeks a Project Engineer to drive process improvements and cost reduction in manufacturing. The role requires a 5+ year background in regulated industries, strong bilingual Spanish/English communication, and experience with IQ/OQ/PQ and process validation.

The candidate will lead cross-functional teams, author technical docs, and coordinate projects across manufacturing, packaging, and equipment changes, aligning with quality and regulatory standards.