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.

Duties: ​

  • Validation and documentation processes in a highly regulated environment.
  • Operate specialized laboratory equipment and computers as appropriate.
  • Interpret and apply GLPs and GMPs.
  • Apply a science-based approach to production.
  • 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.
  • 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
  • Verbal communication
  • Basic technical presentations
  • Personal Organization
  • Dealing with and managing change
  • Technical (Equipment Specific)
  • Analytical Problem Solving
  • Completion and follow-up
  • Computer Literacy
  • Schedule development
  • Facilitation
  • Collaboration
  • Bilingual (Spanish/English)
  • Flexibility to work off-hours

 



Additional Information

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



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