QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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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 the company success and it will be a key contributor in the Process Development Inspection area.

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation and documentation processes in a highly regulated environment.
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to apply science-based approach to production.
• Strong Knowledge on Vision system technologies
• Inspection/packaging Concepts Knowledge
• Development and Execution of Processes/Equipment Characterization
• Establish Testing Strategies
• Design / Development of Characterization Protocols
• Technical Reports Development
• Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies.
• Risk assessments and QRAES knowledge, to support risk assessments activities.
• Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.

Demonstrated skills in the following areas:

• Basic Technical Report writing and Validation Protocol writing
• Basic project management
• Ability to handle multiple projects at one time.
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
• Problem solving skills for the application of scientific and engineering theory
• Skills in the development of hypotheses and approach.
• Working knowledge of financial analysis tools.
• Ability  to delegate and manage the project work of others.

EDUCATION/EXPERIENCE:

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

Skills in the following areas:

• Negotiation, persuasion and facilitation Collaboration
• Project cost development
• Conflict Resolution
• Schedule and resources loading development
• Flexibility to work off-hours

Qualified candidates should send resume in Word format.