Sr. Manufacturing Engineer

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

Juncos, Puerto Rico | Posted on 02/06/2026

Assess the impact of IT reports, applications, software, and hardware changes on manufacturing processes and equipment.

Plan, execute, and document Computer Systems Validation (CSV) activities, including validation protocols, execution, and final reports.

Implement and support manufacturing procedures and documentation changes.

Inspect machinery, equipment, and tools to verify operational efficiency and performance.

Investigate equipment and process deficiencies and initiate corrective actions to ensure product quality.

Ensure manufacturing processes and procedures comply with regulatory and quality system requirements.

Deliver and manage assigned engineering projects in collaboration with cross-functional teams.

Contribute to department and work group objectives through effective collaboration and stakeholder engagement.

Provide technical guidance, coaching, and review of work for lower-level engineers or specialists.

Communicate with senior internal stakeholders and external vendors to exchange technical information and influence decision-making.

*Other duties maybe assigned.*

Requirements

Requirements:

Bachelor’s Degree in Engineering required.

Minimum 4 years of relevant manufacturing engineering experience, or

Minimum 2 years of experience with an advanced engineering degree.

Demonstrated experience performing Computer Systems Validation (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.

Ability to manage complex technical issues involving multiple systems or processes.

Effective communication skills for interaction with internal and external stakeholders.

Skills:

Computer Systems Validation (CSV)

IT Systems Knowledge (manufacturing-related)

Manufacturing Engineering

Equipment Performance Evaluation

Process and Procedure Changes

Regulatory Compliance (cGMP / Quality Systems)

Technical Leadership

Project Management

Root Cause Analysis & Corrective Actions

Cross-Functional Collaboration

Technical Documentation

Stakeholder Communication

Work Schedule & Availability:

• Full-time,onsiteposition.
  
• Availabilityto workextended shifts (8–12 hours).
  
• Availabilityto workweekendsandholidaysas required.
  
• Availabilityto work1st and/or 2nd shift(primarily 1st shift).