Validation Engineer
On-siteAñasco, Añasco, Puerto Rico
Job Summary
Develop, execute, and document validation protocols and reports for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Support validation activities for manufacturing processes, equipment, cleaning procedures, and computerized systems while participating in qualification and requalification efforts. Perform validation impact assessments associated with Change Controls and collaborate with cross-functional teams including Manufacturing, Quality, Engineering, R&D, and Regulatory Affairs. Analyze validation data using statistical tools to support conclusions and maintain accurate documentation in compliance with Good Documentation Practices and FDA, ISO, and cGMP regulations. Support protocol deviations, investigations, corrective actions, and continuous improvement initiatives. Track project timelines and deliverables to ensure successful execution. Assist internal audits and regulatory inspections by providing technical expertise and documentation.
Required Qualifications
- Bachelor's degree in Engineering
- at least two (2) years of previous experience in Validation activities within the Pharmaceutical & Medical Devices Industry
- Bilingual: Spanish and English
- Excellent communication skills
- positive attitude
- Validation Life Cycle (IQ, OQ, PQ)
- Manufacturing processes, equipment, cleaning, and computerized systems validation
- Regulatory requirements and standards (FDA, ISO, cGMP)
- Statistical analysis tools (e.g., Minitab, Excel)
- Change Control and validation impact assessments
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