ZL02-042424 Process Development Scientist

3 weeks ago

, United States Validation & Engineering Group Full time
Job DescriptionJob Description

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.

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