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Senior Validation Specialist

2 months ago

Doral, Florida, United States VIVEX BIOLOGICS INC Full time
Job Summary

Vivex Biologics Inc. is seeking a highly skilled Senior Validation Engineer II to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the reliability, consistency, and compliance of our processes, equipment, and systems.

Key Responsibilities
  • Develop and execute validation plans for new and existing processes, equipment, and systems.
  • Lead specific tasks or larger projects and ensure their successful completion.
  • Generate and execute qualification protocols to perform equipment qualifications and process validations.
  • Support the company's Master Validation Plan (MVP) including commissioning activities and protocols executions.
  • Collaborate with cross-functional teams to provide quality-related guidance and solve technical problems.
  • Conduct data analysis and make recommendations to ensure tissue safety and compliance with standards.
  • Assess the impact of process, material, or equipment changes on validation status and provide guidance on revalidation or change control measures.
  • Identify potential risks associated with manufacturing processes and implement mitigation measures.
  • Train personnel involved in validation activities and offer expertise and support to other departments.
  • Support compliance investigations and recommend corrective and preventive actions.
Requirements
  • Bachelor's degree in engineering or a related technical discipline.
  • At least 4-5 years of experience in a related engineering or quality role.
  • Strong knowledge of FDA, AATB, and cGTP guidelines.
  • Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
  • Strong analytical and problem-solving skills.
  • Effective oral, written, communication, and presentation skills.
Working Conditions

The ideal candidate will be willing to accommodate travel if necessary. The role will be based in an office environment, laboratory environment, and occasional clean room access.