Validation and Qualification Specialist
On-siteGuayama, Guayama, Puerto Rico
Job Summary
Execute and manage the qualification lifecycle for equipment and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Develop, review, and execute validation protocols and reports in accordance with GMP and company standards. Generate and maintain change control documentation for equipment and process modifications. Perform troubleshooting and root cause analysis for validation-related issues. Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements throughout all validation activities. Collaborate with manufacturing, packaging, and quality teams to support equipment qualification and process improvements. Maintain accurate and timely documentation in alignment with internal SOPs and regulatory expectations. This role requires a Bachelor's Degree in Life Sciences or Engineering, bilingual Spanish and English skills, and experience in validation principles, protocols, and lifecycle management. Shifts are administrative and based on business needs.
Required Qualifications
- Bachelor's Degree in Life Sciences or Engineering
- previous exposure to Validation and/or Qualification activities within the pharmaceutical and medical devices industry
- Bilingual: (Spanish and English)
- Experience in Validation principles, protocols, and lifecycle management
- Experience in Manufacturing and packaging equipment
- Experience in GMP & GDP regulations
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