Senior Engineer, Equipment Validation & Compliance

QRC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QRC Group, LLC is seeking a Senior Engineer with experience performing technical assessments of equipment in a regulated pharmaceutical or biotechnology manufacturing environment.

You will prepare, review, and approve technical reports, engineering assessments, equipment evaluations, and technical justifications, while ensuring cgmp compliance and collaboration across Manufacturing, Validation and Quality teams.

Qualifications

• Bachelor's in Engineering and 4+ years of engineering experience.
• Bilingual English & Spanish required.
• Proficiency in technical writing and documentation.

Responsibilities

• Prepare, review, and approve technical reports, engineering assessments, and equipment evaluations.
• Evaluate equipment failures, maintenance history, operating conditions, and potential impact on product quality.
• Provide technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.
• Assess equipment design, functionality, reliability, and lifecycle documentation.

Skills

Bilingual English/Spanish

Technical Writing

Education

Bachelor's in Engineering

Job description

QRC Group, LLC is seeking a Senior Engineer with experience performing technical assessments of equipment in a regulated pharmaceutical or biotechnology manufacturing environment.

You will prepare, review, and approve technical reports, engineering assessments, equipment evaluations, and technical justifications, while ensuring cgmp compliance and collaboration across Manufacturing, Validation and Quality teams.