Quality Engineer/ Scientist


VALIDATION & ENGINEERING GROUP

Company Description

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services in Puerto Rico and USA.

Job Description

Support Quality Assurance program:

  • Non Conformances
  • Review and approve product MPs.
  • Approve validation protocols and reports for manufacturing processes.
  • Approve Environmental Characterization reports.
  • Lead investigations.
  • Review Risk Assessments.
  • Support Automation activities.
  • Support facilities and environmental programs.
  • Approve investigations and CAPA records.
  • Approve change controls.

Qualifications

  • Bachelor’s degree Sciences o Engineering and 3 to 5 years of directly related experience.
  • Project management skills.
  • Strong organizational skills.
  • Strong knowledge in area of expertise.
  • Collaborate and coordinate with higher level outside resources.
  • Strong knowledge of and experience with processes involved in manufacturing and distribution.
  • Validation and process development.
  • Demonstrate ability to interact with regulatory agencies.
  • Strong word processing, presentation, database and spreadsheet application skills.
  • Strong communication (both written and oral), facilitation and presentation skills.
  • Ability to evaluate compliance issues.
  • Available to work non-standard shifts requested.
  • Fully Bilingual (Spanish & English).

Additional Information

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

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