Subject Matter Expert (SME) – Pharmaceutical Manufacturing Automation

Job overview

The Subject Matter Expert (SME) – Pharmaceutical Manufacturing Automation role is onsite in Manatí, PR; compensation is not specified. The role supports pharmaceutical manufacturing or packaging technologies and works with Engineering, Manufacturing, Packaging, Quality, Validation, and external suppliers. The SME provides technical expertise for equipment and automated systems throughout implementation, troubleshooting, qualification, optimization, and lifecycle activities. The work supports reliable operations and compliance with applicable GMP requirements through technical coordination, qualification documentation, investigations, and guidance to engineering and operational personnel.

What you'll do

• Provide technical expertise for manufacturing or packaging equipment, automated systems, and processes
• support automation initiatives, equipment integration, upgrades, and operational improvements
• troubleshoot equipment, process, and control-system issues
• support technology transfer, equipment readiness, process improvements, and manufacturing
• develop, review, and execute commissioning and qualification documentation
• participate in FAT, SAT, startup, and equipment turnover
• assess changes for quality, process, and validated-state impacts
• support investigations, root cause analysis, CAPAs, and change controls
• coordinate vendors and cross-functional teams
• provide technical guidance and training.

What we're looking for

Skills & competencies

subject matter expert

pharmaceutical manufacturing

manufacturing automation

packaging technologies

technical services

commissioning and qualification

gmp

equipment qualification

plc

hmi

scada

manatí pr

onsite

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in a listed engineering or related technical discipline, relevant experience in pharmaceutical, biotechnology, or regulated manufacturing environments, and English and Spanish communication skills. PLC, HMI, SCADA, GMP, qualification, and data-integrity knowledge are specified; previous technical-lead or SME experience and computerized system validation familiarity are preferred.

About the employer

LEGAL PROJECT MANAGEMENT PARTNERS LLC is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.