Senior Validation Specialist

hace 1 día


San Juan, San Juan, Puerto Rico Mentor Technical Group A tiempo completo

Mentor Technical Group provides comprehensive technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering, we have the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.

Job Summary: We are seeking a meticulous and experienced validation engineer specializing in serialization to join our team. The ideal candidate will be responsible for ensuring that serialization processes and systems meet industry standards and regulatory requirements.

Key Responsibilities:

  • Develop and execute validation protocols for serialization equipment, processes, and systems.
  • Document validation activities and results, maintaining comprehensive records for all validation activities.
  • Analyze validation test data to determine whether systems or processes meet validation criteria.
  • Ensure all serialization systems are running according to necessary specifications and comply with regulatory standards.
  • Collaborate with production staff to ensure operational consistency and effectiveness.
  • Coordinate with Quality Assurance and Engineering departments to ensure timely execution of validation activities.
  • Investigate and resolve issues that could impact product quality and serialization integrity.
  • Participate in quality audits and respond to audit findings with appropriate corrective actions.
  • Stay current with industry trends and regulatory standards to ensure validation processes are up-to-date.


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