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

Habilidades requeridas

Regulatory technical assessments supporting FDA commitmentsRoot cause analysisDeviation investigationsCAPA development and implementationEquipment evaluation and lifecycle assessmentReview and interpretation of engineering drawings and technical documentationTechnical report writing / Technical writingcGMP compliance and inspection readinessCross-functional collaboration with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and vendorsRisk assessmentManufacturing-floor inspections and verification of operating conditionsExperience with purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systemsBilingual (English and Spanish)

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