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

Sr Engineer with experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment, with the ability to independently manage technical assessments, corrective actions, and equipment improvement initiatives.

• Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
• Supporting technical investigations, identifying equipment failure mechanisms, and developing corrective and preventive actions to reduce recurrence.
• Evaluating the applicability of CAPA and lessons learned to other equipment, systems, and manufacturing areas.
• Managing engineering activities in IBM Maximo, including work order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
• Developing and revising preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.
• Implementing engineering controls and completing actions associated with safety incidents and INCA records.
• Supporting equipment troubleshooting, repair coordination, replacement of obsolete equipment, spare parts evaluations, and equipment modernization projects.
• Working with bio pharmaceutical manufacturing equipment such as centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizes, filter integrity testers, and associated instrumentation.
• Preparing clear technical reports and assessment rationales, maintaining traceable supporting documentation, and completing actions within established deadlines.
• Coordinating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
• Managing multiple concurrent assignments and prioritizing work according to safety, quality, and operational needs..

Qualifications

• Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience (Chemical, Mechanical or Electrical Engineer)

Bilingual (Spanish/English)

Additional Information

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