Process Development Scientist

hace 3 semanas


Juncos, Puerto Rico QRC Group, Inc A tiempo completo
Job Description

Process Development Scientist with working knowledge of pharmaceutical/biotech processes.

Experience in:

  • Validation and documentation processes in a highly regulated environment.
  • Interpret and apply GLPs and GMPs.
  • Ability to apply a science-based approach to production.
  • Vision system technologies (strong knowledge).
  • Inspection/packaging Concepts.
  • 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.
     

Qualifications

  • Doctorate degree or Master's degree and 5 years of Scientific experience or
    Bachelor's degree and 6 years of Scientific experience
  • Basic technical report writing and Validation Protocol Writing
  • Basic technical presentations
  • Dealing with and managing change
  • Analytical Problem Solving
  • Computer Literacy
  • Schedule development
  • Facilitation/Collaboration
  • Basic project management
  • Completion and follow-up
  •  Specialized equipment/process expertise
  • Interacts effectively with a 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
  • Bilingual (Spanish/English)(Write/Speak)

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

 



Additional Information

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



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