Sr. Engineer

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.