Sr Parenteral Inspection Technology Engineer

JC Automation Corp • Manatí, PR

42d

About The Position

We are seeking a Senior Inspection Technology Engineer to lead inspection engineering activities for sterile and biologics parenteral products. This role combines deep technical expertise in automated inspection systems with hands-on project leadership — from technology development and implementation to validation, line trials, and operational support. The ideal candidate brings strong problem-solving capabilities, experience in pharmaceutical sterile manufacturing, and the cross-functional collaboration skills needed to align inspection efforts with manufacturing, quality, and validation teams.

Requirements

• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or Automation), Computer Science, or a related technical discipline.
• Strong foundation in inspection engineering activities specifically for sterile and biologics parenteral products.
• Proven track record in the development, deployment, and lifecycle management of automated inspection technologies.
• Extensive hands-on experience executing equipment validation protocols, managing line trials, and supporting product transfers.
• Advanced troubleshooting capabilities for complex inspection equipment and control systems.
• Demonstrated ability to lead process improvements and manage inspection-related projects end-to-end.
• Experience in pharmaceutical sterile manufacturing environments with knowledge of cGMP and FDA requirements.

Nice To Haves

• Experience with automated vision inspection systems or machine learning-based inspection technologies.
• Familiarity with lyophilized parenteral products and associated inspection challenges.
• PMP or equivalent project management certification.
• Experience supporting regulatory audits or inspections related to parenteral inspection systems.

Responsibilities

• Lead the development, deployment, and lifecycle management of new parenteral inspection technologies and automated inspection systems for sterile and biologics products.
• Identify and lead process improvement initiatives related to inspection systems. Manage inspection-related capital or operational projects to maximize efficiency, quality, and compliance.
• Execute equipment validation protocols, manage line trials, and support seamless product transfers, ensuring all activities are documented and compliant with regulatory standards.
• Apply advanced technical problem-solving capabilities to troubleshoot complex inspection equipment and resolve operational bottlenecks in a timely manner.
• Partner closely with manufacturing, engineering, quality, and validation teams to ensure inspection systems meet site priorities and stringent regulatory requirements.
• Ensure all inspection engineering activities are aligned with cGMP regulations, FDA guidelines, and internal site procedures throughout the product lifecycle.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior