Senior Manufacturing Engineer: CSV & IT Change Lead

Medial Group; Juncos (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico, is seeking a Manufacturing Engineer to assess IT and manufacturing changes, plan and execute CSV activities, and guide cross-functional teams to ensure process and product quality.

The role requires a bachelor’s in engineering, 4+ years of applicable experience or 2 years with an advanced degree, and strong regulatory knowledge. Onsite schedule may include extended shifts and weekend work as needed.

Qualifications

• Bachelor’s Degree in Engineering required.
• 4+ years of manufacturing engineering experience or 2 years with an advanced degree.
• Experience performing CSV in a regulated environment.
• Experience assessing and managing manufacturing and IT-related system changes.
• Proven experience leading technical initiatives or projects.
• Strong understanding of regulatory compliance requirements.

Responsibilities

• Plan, execute, and document CSV activities, including validation protocols, execution, and final reports.
• Implement and support manufacturing procedures and documentation changes.
• Inspect machinery, equipment, and tools to verify performance.
• Investigate deficiencies and initiate corrective actions to ensure product quality.
• Ensure processes comply with regulatory and quality system requirements.
• Deliver and manage assigned engineering projects with cross-functional teams.
• Provide technical guidance and review of work for junior staff.
• Communicate with senior stakeholders and external vendors to exchange technical information.

Skills

CSV Validation

IT Systems Knowledge

Manufacturing Engineering

Equipment Performance

Process Changes

Regulatory Compliance

Technical Leadership

Project Management

Root Cause Analysis

Cross-Functional Collaboration

Technical Documentation

Stakeholder Communication

Education

Bachelor’s Degree in Engineering

Job description

Medial Group in Juncos, Puerto Rico, is seeking a Manufacturing Engineer to assess IT and manufacturing changes, plan and execute CSV activities, and guide cross-functional teams to ensure process and product quality.

The role requires a bachelor’s in engineering, 4+ years of applicable experience or 2 years with an advanced degree, and strong regulatory knowledge. Onsite schedule may include extended shifts and weekend work as needed.