Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Process Development Scientist

Requirements:

• Doctorate degree or
• Master degree and 5 years of Scientific experience or
• Bachelor degree and 6 years of Scientific experience

Qualifications:

• Ability to operate specialized laboratory equipment and computers as appropriate.
• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation and documentation processes in a highly regulated environment
• Ability to interpret and apply GLPs and GMPs.
• 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.
• Able to develop solutions to routine technical problems of limited scope.
• 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
  • Verbal communication
  • Basic technical presentations
  • Personal Organization
  • Dealing with and managing change
  • Technical (Equipment Specific)
  • Analytical Problem Solving
  • Computer Literacy
  • Schedule development
  • Facilitation
  • Collaboration
  • Basic project management
  • Completion and follow-up
• Specialized equipment/process expertise.
• Interacts effectively with variety of communication and working styles.
• 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.
• 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.