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 in:

• Work orders requestor, approver, may execute and document specific type of WOs (RSO) as applicable
• Change Controls assessor
• Change Control development & presenter
• CAPA proposal and implementation plan development & presenter
• URS’s, RD’s, DS’s reviewer / approver /owner
• Maintenance Master Package (MMP) reviewer / approver / owner
• Test Runs / Protocols (PTCs) reviewer / approver / execution and/or support (may be author in very specific cases)
• FAT's / SAT's author / reviewer / approver / execution and/or support
• Functional tests author / reviewer / approver / execution and/or support
• IOQ / PQ reviewer / execution and/or support
• P&ID and official drawings reviewer / approver / owner
• SOP & Forms: author / reviewer / approver /owner (equipment systems), reviewer (process)
• Job Plans development, reviewer and maintenance
• Spare parts reviewer, approver and maintenance
• Troubleshooting support as required by operations / engineering
• Downtime incidents as per Equipment Failure, prepare recommendations, create action plans and execute to eliminate recurrence
• Review equipment / system Root Cause Analysis investigation
• Risk assessment and continuous improvement initiatives (Kaizens, critiques, VSMs)
• Generate or support the generation of One-point-lessons for systems / equipment
• Identify, evaluate, develop / design, plan and implement solutions for equipment / process improvement opportunities
• Development, execution and implementation of corrective and preventive actions (CAPAs)
• Generation of training materials and in providing training on scientific, technical operations aspects of the equipment / systems.

Qualifications

• Doctorate or Masters + 2 years of Engineering experience or Bachelor in Engineering + 4 years of Engineering experience.
  (Mechanical Engineering and Electrical Engineering preferred options)
• Bilingual (English/Spanish)(Speak/Write)
• Computer Literacy​

Additional Information

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