Project Engineer

CIS International•Humacao, PR

18h•Onsite

About The Position

The Project Engineer provides direct technical and operational support to Project Managers leading capital projects within a regulated medical device manufacturing environment. This role is responsible for coordinating engineering activities, supporting equipment and system implementations, and ensuring that validation, product transfer, and project execution requirements are met in compliance with industry standards and regulatory expectations. Key Responsibilities Support Project Managers in the planning, execution, and monitoring of capital projects, including equipment upgrades, facility modifications, and new system installations. Lead or support equipment and system validations (IQ/OQ/PQ), ensuring documentation, protocols, and reports meet regulatory and internal quality requirements. Coordinate product transfer activities, including process mapping, equipment readiness, documentation updates, and cross-functional alignment. Assist in the development of project schedules, budgets, risk assessments, and resource plans. Prepare and maintain technical documentation, including URS, FAT/SAT protocols, engineering drawings, change controls, and project reports. Collaborate with manufacturing, quality, maintenance, and supply chain teams to ensure smooth project execution and minimal operational disruption. Support troubleshooting, root cause analysis, and implementation of corrective/preventive actions related to equipment or process issues. Ensure all project activities comply with FDA, ISO, and internal quality system requirements. Manage vendor interactions, including equipment specifications, quotations, installation coordination, and performance verification. Track project progress and provide timely updates, metrics, and presentations to project leadership.

Requirements

Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial, Biomedical, Chemical, or related field).
Minimum 3–5 years of experience in a regulated manufacturing environment, preferably medical devices, pharmaceuticals, or biotech.
Demonstrated experience in equipment and system validations, including protocol development and execution.
Hands-on experience with capital projects, equipment installation, commissioning, and qualification.
Experience supporting product transfers, scale-up, or process implementation.
Strong understanding of manufacturing equipment, automation systems, utilities, and production workflows.
Knowledge of FDA regulations, ISO standards, and Good Manufacturing Practices (GMP).
Proficiency in project management tools and engineering documentation practices.
Excellent communication, organization, and cross-functional collaboration skills.
Languages: Spanish and English

Nice To Haves

Experience in validations and capital projects for new equipments and products introduction or transfer
Familiarity with risk management tools (FMEA, hazard analysis).
Experience working with external vendors, contractors, and engineering firms.

Responsibilities

Support Project Managers in the planning, execution, and monitoring of capital projects, including equipment upgrades, facility modifications, and new system installations.
Lead or support equipment and system validations (IQ/OQ/PQ), ensuring documentation, protocols, and reports meet regulatory and internal quality requirements.
Coordinate product transfer activities, including process mapping, equipment readiness, documentation updates, and cross-functional alignment.
Assist in the development of project schedules, budgets, risk assessments, and resource plans.
Prepare and maintain technical documentation, including URS, FAT/SAT protocols, engineering drawings, change controls, and project reports.
Collaborate with manufacturing, quality, maintenance, and supply chain teams to ensure smooth project execution and minimal operational disruption.
Support troubleshooting, root cause analysis, and implementation of corrective/preventive actions related to equipment or process issues.
Ensure all project activities comply with FDA, ISO, and internal quality system requirements.
Manage vendor interactions, including equipment specifications, quotations, installation coordination, and performance verification.
Track project progress and provide timely updates, metrics, and presentations to project leadership.