Sr. Engineer

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

Company Description

is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

We are seeking a

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

We are seeking a Senior Engineer with experience performing technical assessments of equipment in a regulated pharmaceutical or biotechnology manufacturing environment.

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.

Qualifications

• Bachelors in Engineering + 4 years of Engineering experience.
• Bilingual (English & Spanish).
• Technical Writing.

Additional Information

All your information will be kept confidential according to EEO guidelines.