Job Description

We are seeking a Senior Engineer with hands-on experience with technical assessments supporting FDA/regulatory commitments, manufacturing-floor investigations, root cause analysis, deviation investigations, and CAPA development and implementation. Key Responsibilities & Qualifications: • Preparation, review, and approval of technical reports, engineering assessments, equipment evaluations, and technical justifications. • Evaluation of equipment failures, performance issues, maintenance history, operating conditions, and potential impact to product, process, quality, and equipment qualified state. • Technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments. • Assessment of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use. • Review and interpretation of engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data. • Development of clear, factual, and scientifically justified conclusions and recommendations based on available evidence. • Experience collaborating with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to obtain and evaluate technical information. • Knowledge of cGMP requirements and the ability to ensure that technical assessments are complete, traceable, inspection-ready, and supported by objective evidence. • Strong technical writing, problem-solving, and communication skills, with the ability to independently manage multiple assessments and deliverables. • Experience with purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systems is preferred. • Strong field presence and willingness to inspect equipment and verify actual operating conditions within manufacturing areas. Requirements Bachelors in Engineering + 4 years of Engineering experience. Bilingual (English & Spanish). Technical Writing