Sr Parenteral Inspection Technology Engineer

Job Description

Job Description

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

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.

RESPONSIBILITIES

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

REQUIREMENTS & QUALIFICATIONS

Required

• 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.

Preferred

• 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.

SKILLS

Technical Skills

• Inspection engineering for sterile and biologics parenteral products
• Automated inspection system development, implementation, and lifecycle management
• Equipment validation protocols (IQ/OQ/PQ) and line trial execution
• Advanced troubleshooting of inspection equipment and control systems
• Process improvement methodologies in regulated manufacturing environments
• cGMP compliance, FDA guidelines, and regulatory documentation
• Microsoft Office 365

Soft Skills

• Strong cross-functional collaboration with manufacturing, quality, and validation teams
• Technical leadership and subject matter expertise
• Structured problem-solving and root cause analysis
• Project management and execution in high-complexity environments
• Clear technical communication with multidisciplinary stakeholders
• Adaptability and availability to support other shifts as business needs require