Packaging Engineer - Guayama, PR

Position Summary :

We are seeking an experienced and highly motivated Senior Packaging Engineer to lead and support packaging initiatives for solid oral dosage pharmaceutical products. The successful candidate will be responsible for overseeing packaging equipment projects, executing and supporting packaging validation activities, and driving improvements to the packaging process. This role is critical to ensuring efficiency, compliance, and innovation of packaging operations within a regulated cGMP environment.

Key Responsibilities :

• Project Management :
• Lead packaging equipment selection, procurement, installation, commissioning, and qualification (IQ / OQ / PQ) projects.
• Collaborate with cross-functional teams (Engineering, Production, QA, RA, Procurement) to ensure timely and cost-effective execution of packaging projects.
• Packaging Validation & Compliance :
• Develop and execute validation protocols (IQ / OQ / PQ) for packaging lines, equipment, and processes.
• Ensure compliance with FDA, EU, and other applicable regulatory requirements and industry best practices.
• Author and review technical documents including URS, FAT / SAT protocols, risk assessments, and change controls.
• Process Improvement :
• Identify and implement process and equipment improvements to enhance packaging efficiency, product quality, and line throughput.
• Support as a SME in identifying the root causes of packaging defects or inefficiencies and implementing corrective and preventive actions (CAPAs).
• Lead packaging line optimization and lean manufacturing initiatives.
• Mentorship and Leadership :
• Serve as a subject matter expert (SME) for packaging systems and technologies.
• Innovation and Technology :
• Stay abreast of emerging packaging technologies and trends relevant to solid dosage forms.
• Evaluate and implement innovative packaging materials or solutions to support new product introductions or sustainability goals.

Preferred Skills :

Requirements

Qualifications :