Manufacturing Engineer - Process Optimization & Compliance

CIS International LLC; Villalba (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

CIS International LLC is seeking a Manufacturing Engineer to design, develop, validate, and sustain manufacturing processes and equipment in a regulated environment. The role emphasizes cross‑functional support and delivering high‑quality production outcomes.

The candidate will lead process improvements, CAPA investigations, and implement SPC methods while ensuring compliance with regulatory and quality requirements. It is a full‑time, on‑site position based in Villalba, Puerto Rico.

Qualifications

• Bachelor's degree required in Engineering.
• Minimum of 2 years of relevant manufacturing engineering experience in the regulated industry.

Responsibilities

• Design, develop, and optimize manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Design plant and equipment layouts to ensure efficient, safe, and productive manufacturing operations.
• Define sequences of operations and specify procedures for fabrication of tools, fixtures, and equipment impacting product performance.
• Adapt machine and equipment designs to meet factory and production conditions.
• Incorporate inspection and testing requirements into production and validation plans.
• Perform process and equipment performance evaluations to verify efficiency, capability, and compliance.
• Lead and support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA) to ensure product quality.
• Provide technical and sustaining engineering support to manufacturing operations.
• Develop and support manufacturing processes applicable to Statistical Process Control (SPC).
• Apply statistical techniques to analyze process performance and drive continuous improvement.
• Ensure manufacturing processes and procedures comply with applicable regulatory and quality requirements.
• Support and execute Process Validation, Equipment IQ, and Computer Software Validation activities.
• Provide technical guidance to design and engineering teams to ensure optimal use of equipment and manufacturing techniques.
• Participate in cross-functional meetings and project teams to meet operational and project objectives.
• Support project scheduling and execution to ensure deadlines are met without operational impact.
• May mentor or provide guidance to entry-level engineers or support personnel.

Skills

Process Validation

CAPA investigations

SPC

Education

Bachelor’s degree in Engineering

Tools

Equipment IQ

Computer Software Validation

Job description

CIS International LLC is seeking a Manufacturing Engineer to design, develop, validate, and sustain manufacturing processes and equipment in a regulated environment. The role emphasizes cross‑functional support and delivering high‑quality production outcomes.

The candidate will lead process improvements, CAPA investigations, and implement SPC methods while ensuring compliance with regulatory and quality requirements. It is a full‑time, on‑site position based in Villalba, Puerto Rico.