Sr Engineer

QRC Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group, LLC in Juncos, Puerto Rico is seeking a Senior Engineer to support FDA/regulatory commitments, manufacturing-floor investigations, root cause analysis, deviation investigations, and CAPA development and implementation.

You will prepare technical reports and engineering assessments, review equipment histories and specifications, and collaborate with Manufacturing, Quality, Validation, and external vendors to deliver traceable, inspection-ready conclusions based on robust evidence.

Qualifications

• Bachelor's in Engineering with 4+ years of experience required.
• Experience preparing technical reports, engineering assessments, and justifications.
• Knowledge of cGMP and regulatory commitments preferred.

Responsibilities

• Prepare, review, and approve technical reports and engineering assessments.
• Evaluate equipment failures, performance history, and potential impact on product quality.
• Provide technical support for deviations, CAPAs, change controls, and risk assessments.
• Assess equipment design, lifecycle, maintenance strategies, and fitness for use.
• Review drawings, vendor docs, manuals, calibration records, and data history.
• Collaborate with Manufacturing, Quality, Validation, and vendors to obtain technical information.

Skills

Technical report writing

Cross-functional collaboration

Problem solving

Strong communication

Education

Bachelor's degree in Engineering

Job description

Juncos, Puerto Rico | Posted on 09/29/2026

We are seeking a Senior Engineer with hands‑on experience with technical assessments supportingFDA/regulatory commitments, manufacturing‑floor investigations, root causeanalysis, 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.