Sr Parenteral Inspection Technology Engineer

Job DescriptionJob DescriptionAbout 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 ROLEWe 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.

RESPONSIBILITIESInspection 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 & QUALIFICATIONSRequiredBachelor'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.

PreferredExperience 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.

SKILLSTechnical SkillsInspection engineering for sterile and biologics parenteral productsAutomated inspection system development, implementation, and lifecycle managementEquipment validation protocols (IQ/OQ/PQ) and line trial executionAdvanced troubleshooting of inspection equipment and control systemsProcess improvement methodologies in regulated manufacturing environmentscGMP compliance, FDA guidelines, and regulatory documentationMicrosoft Office 365

Soft SkillsStrong cross-functional collaboration with manufacturing, quality, and validation teamsTechnical leadership and subject matter expertiseStructured problem-solving and root cause analysisProject management and execution in high-complexity environmentsClear technical communication with multidisciplinary stakeholdersAdaptability and availability to support other shifts as business needs require