Sr Engineer
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
Requirements
Education: Doctorate + 2 years of Project Management experience or Masters + 4 years of Project Management experience or Bachelors + 6 years of Project Management experience or Associates + 10 years of Project Management experience or High school/GED + 12 years of Project Manage Change Control experience Fluent business English and Spanish, written and oral Effective verbal and written communication skills (writing and presentations). Understanding and experience with Ariba Sourcing and Contracting Modules. Experience with SAP, Trackwise and Project management tools preferred. Highly proficient with MS Office, including Excel, Word and PowerPoint Practical project management software and spreadsheet skills, proficient computer operation skills.