Senior Engineer

  • Contract

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

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects   environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. This role is crucial for Amgen’s success and it will be a key contributor in the Process development Inspection area.

PREFERRED QUALIFICATIONS

  • Familiarity with validation and documentation processes in a highly regulated environment.
  • Ability to operate specialized laboratory equipment and computers as appropriate.
  • Strong Knowledge on Vision system technologies
  • Development and Execution of Processes/Equipment Characterization: Design / Development of Characterization Protocols; Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies; Risk assessments and QRAES knowledge, to support risk assessments activities.
  • Demonstrated skills in the following areas: Basic technical report writing and Validation Protocol Writing; Basic project management
  • Working knowledge of financial analysis tools.
  • Ability  to delegate and manage the project work of others.
  • Flexibility to work off-hours - NON-STANDARD SHIFT

Qualifications

  • Master’s degree OR Bachelor’s degree in Engineering & 
  • 5 years of Engineering experience.

Additional Information

  • Willing to work in a Non-Standard Shift
  • Qualified candidates should send resume in Word format.