Sr. Engineer
Jornada completa
QRC Group, Inc
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 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.
Vacante publicada el 1 día atrás
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