Packaging Engineering Lead — GMP Equipment Excellence

Zvh; Guayama (PR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off (PTO)

Life and disability insurance

Job summary

Baxter is seeking a Senior Engineer - Packaging to lead the design, installation, qualification, and optimization of packaging systems across filling operations. You will work closely with Manufacturing, Quality, Maintenance, Validation, Supply Chain, and Site Engineering to drive reliability and compliance throughout the project lifecycle.

The role requires a Bachelor's in Mechanical/related engineering discipline, 5–8 years in regulated manufacturing, and experience with IQ/OQ/PQ, SPC, OEE,

Qualifications

• Bachelor's Degree in Mechanical Engineering or related field.
• 5–8 years of engineering experience in Pharmaceutical/Medical Device/ Biotechnology or Chemical Manufacturing environments.
• Experience leading packaging equipment installations, upgrades, qualifications, and validation activities.

Responsibilities

• Lead design, installation, commissioning, qualification, and validation of new packaging equipment and systems.
• Drive packaging process optimization to improve safety, quality, productivity, and cost performance.
• Implement SPC programs for Filling and Packaging operations and apply appropriate statistical methodologies during qualification activities.
• Develop and maintain systems to monitor documentation errors, identify trends, and implement corrective actions to improve compliance and performance.
• Lead maintenance strategy shifts toward predictive and reliability-centered maintenance; develop packaging and filling performance metrics (OEE).
• Coordinate projects, manage budgets, schedules, and resources, and communicate status to site leadership.

Skills

Packaging Equipment

Project Management

Validation

Process Optimization

Statistical Analysis

OEE Metrics

Root Cause Analysis

Lean/Six Sigma

Education

Bachelor's Degree in Mechanical Engineering

Tools

IQ/OQ/PQ Validation

SPC Tools

Job description

Baxter is seeking a Senior Engineer - Packaging to lead the design, installation, qualification, and optimization of packaging systems across filling operations. You will work closely with Manufacturing, Quality, Maintenance, Validation, Supply Chain, and Site Engineering to drive reliability and compliance throughout the project lifecycle.

The role requires a Bachelor's in Mechanical/related engineering discipline, 5–8 years in regulated manufacturing, and experience with IQ/OQ/PQ, SPC, OEE,