Quality Assurance Specialist

hace 6 días


Juncos, Puerto Rico Quality Consulting Group A tiempo completo

Company Overview

Quality Consulting Group, a leading provider of quality consulting services, is seeking an experienced validation engineer to join our team. We provide expert support to clients in the pharmaceutical, biotech, medical devices, and manufacturing industries.

About the Role

In this challenging role, you will work closely with our team to provide technical validation engineering support for process and equipment upgrades, replacements, and modifications. You will be responsible for troubleshooting systemic validation issues, applying advanced validation principles, and developing policies and procedures.

Responsibilities

  • Provide technical validation engineering support for process and equipment upgrades, replacements, and modifications.
  • Troubleshoot systemic validation issues.
  • Apply advanced validation principles to design and implementation of major system or process modifications and/or capital projects.
  • Develop policies and procedures for validation engineering.
  • Supervise and review work of a small staff of engineers and technicians on ongoing basis as well as on project basis.
  • Develop technical solutions to complex problems requiring regular use of ingenuity and creativity.

Qualifications

Bachelor's degree in related field of engineering (any field) or scientific background (Biology, Microbiology, Biotechnology, Chemistry, etc.). 5 years of directly related experience in regulated environment (Biotechnology, Pharmaceutical, Medical Devices, etc.). Experience in Validation with preference in Process Validation. Basic project management knowledge.



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