JT760 - SR. ENGINEER

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA
 

RESPONSIBILITIES

• Provide technical and process-development support to commercial pharmaceutical, biotechnology, medical-device, or combination-product manufacturing operations.
• Support projects related to process improvements, equipment upgrades, new product introductions, technology transfers, and implementation of new inspection or packaging technologies.
• Investigate inspection rejects, packaging defects, yield losses, equipment alarms, and process deviations using structured root-cause-analysis methodologies.
• Support process qualification and validation activities, including IQ/OQ/PQ, process performance qualification, test-method validation, and continued process verification/process monitoring.
• Develop, review, and maintain technical documentation, including protocols, study reports, engineering assessments, investigation reports, risk assessments, work instructions, and change controls.
• Analyze process data and performance trends using statistical and data-analysis tools.
• Support manufacturing operations through effective on-the-floor technical assistance and troubleshooting.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory Affairs.
• Support GMP-regulated quality-system processes, including deviations, CAPAs, nonconformances, complaints, change controls, and data-integrity requirements.
• Provide timely, data-driven technical recommendations while maintaining compliance, product quality, and operational objectives.

QUALIFICATIONS

• Bachelor's degree in Engineering
• 4 years of Engineering experience.
• Direct experience supporting commercial pharmaceutical, biotechnology, medical-device, or combination-product manufacturing operations.
• Project management experience.
• Experience with sterile injectable products, prefilled syringes, autoinjectors, pens, or other drug-device combination products.
• Knowledge of packaging operations, including primary and secondary packaging, labeling, cartoning, and packaging-line troubleshooting.
• Experience investigating inspection rejects, packaging defects, yield losses, equipment alarms, and process deviations.
• Strong knowledge of structured root-cause analysis and problem-solving methodologies.
• Experience authoring or reviewing technical protocols, study reports, engineering assessments, investigation reports, risk assessments, work instructions, and change controls.
• Knowledge of process qualification and validation activities, including IQ/OQ/PQ, PPQ, test-method validation, and continued process verification/process monitoring.
• Experience with statistical and data-analysis tools, including trend analysis, control charts, process capability, variability assessments, and monitoring limits.
• Knowledge of GMP-regulated manufacturing and quality systems, including deviations, CAPAs, nonconformances, complaints, change controls, and data integrity.
• Experience working cross-functionally with Manufacturing, QA, QC, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory Affairs.
• Experience supporting process improvements, equipment upgrades, new product introductions, technology transfers, or new inspection and packaging technologies.
• Ability to provide effective on-the-floor support, communicate clearly with operations personnel, and make timely, data-driven technical decisions.
• Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.