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Lead Validation Engineer

2 months ago

Miami, Florida, United States VIVEX BIOLOGICS INC Full time
Job Overview

Position Summary

The Validation Engineer plays a crucial role in ensuring the dependability, uniformity, and adherence of our operational processes, machinery, and systems to fulfill regulatory standards and quality benchmarks. This position primarily focuses on the development and implementation of validation documentation, including User Requirements Specifications, Installation and Operational Qualification Protocols, Performance Qualification Protocols, and Validation Summary Reports. The Validation Engineer will also take the lead in or assist with the validation of processes, equipment, cleaning, and computer systems.

Key Responsibilities

  • Oversee specific assignments or larger initiatives, ensuring their successful execution independently.
  • Formulate and implement validation strategies for both new and existing processes, equipment, and systems.
  • Create and execute qualification protocols to conduct equipment qualifications and process validations, which includes setting performance criteria, troubleshooting equipment, and ensuring adherence to safety and quality regulations.
  • Support the company's Master Validation Plan (MVP), including commissioning tasks and protocol executions, while establishing re-validation criteria.
  • Collaborate with interdisciplinary teams to provide quality-related insights, resolve technical challenges, and contribute to project milestones.
  • Perform data analysis and provide recommendations to ensure tissue safety, quality, and compliance with established standards.
  • Conduct trend analysis of relevant quality metrics to propose initiatives for enhancement and/or corrective measures as necessary.
  • Evaluate the impact of changes in processes, materials, or equipment on validation status and offer guidance on revalidation or change control procedures.
  • Identify potential risks linked to manufacturing processes and implement suitable mitigation strategies to effectively minimize those risks.
  • Educate personnel involved in validation processes and provide expertise and support to other departments regarding validation-related issues.
  • Assist in compliance investigations and recommend corrective and preventive actions as required.
  • Ensure compliance with all federal, state, company, and regulatory body regulations, policies, and procedures.
  • Mentor and guide fellow engineers, promoting their technical growth and professional development.

Qualifications

  • Bachelor's degree in engineering or a related technical field (e.g., Biology, Chemistry, etc.). Proficiency in microbiology is preferred.
  • A minimum of 4-5 years of experience in a related engineering or quality role, with a preference for validation experience.
  • Strong understanding of FDA, AATB, and cGTP guidelines is preferred.
  • Experience in the Tissue Banking, Pharmaceutical, Medical Device, or Biologics sectors.
  • Familiarity with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs) is preferred.
  • Proficient in relevant software applications (Microsoft Project, Word, Excel, and PowerPoint).
  • Excellent oral, written, communication, and presentation skills.
  • Strong analytical and problem-solving capabilities.
  • Project management skills are preferred.
  • Ability to assertively influence others and lead significant changes.

Working Conditions

Willingness to travel if necessary. The role involves working in an office environment, laboratory settings, and occasional access to clean rooms, with exposure to human tissue and associated hazards.

Physical Requirements

While performing the duties of this position, the employee is regularly required to sit for extended periods. Occasionally, the employee may need to pull, lift, or move up to 20 pounds.

Direct Reports

This is an individual contributor role with no direct reports.