Sr Engineer
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Key details
- Location
- Juncos, PR, United States
- Work style
- Onsite
- Level
- Senior
- Job type
- Contract
- Experience
- 4–7 yrs
- Function
- Software engineering
- Focus area
- other
- Posted
- 2w ago
Skills
calibrationcapachange controlengineering drawingsequipment inspectiongmprisk assessmentroot cause analysistechnical supporttechnical writing
About the role
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
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