Equipment Qualification Specialist
Legal Project Management Partners
- Manatí, PR
- Permanente
- Tiempo completo
- Lead and execute equipment qualification activities (URS, IQ, OQ, PQ, traceability matrix) for pharmaceutical manufacturing equipment used in sterile manufacturing areas.
- Develop, review, and approve qualification protocols and reports with emphasis on process equipment (e.g., filling lines, blisters, cappers, lyophilizes, utilities tied directly to manufacturing).
- Ensure all qualification activities comply with cGMP, U.S. Food and Drug Administration requirements, and internal procedures.
- Perform and document installation verification, functional testing, and performance qualification of manufacturing equipment.
- Support risk assessments (e.g., FMEA) related to equipment qualification.
- Manage and support deviations, investigations, and CAPAs associated with equipment qualification activities.
- Initiate and support Change Control processes, ensuring proper impact assessment on qualified equipment.
- Collaborate with Manufacturing, Engineering, Validation, and Quality teams to ensure equipment readiness and compliance.
- Maintain accurate documentation including protocols, test scripts, reports, and SOPs, ensuring full traceability.
- Support requalification and lifecycle management of manufacturing equipment.
- Fluent in Spanish and English (spoken and written).
- Strong knowledge of documentation practices and data integrity.
- Proficiency in Microsoft Office 365 (Excel, Word, PowerPoint, Teams, SharePoint).
- Strong technical writing and communication skills.
- Ability to work in a cross-functional team environment.
- Detail-oriented with strong problem-solving skills.
- Bachelor's Degree in Engineering, Life Sciences, or related field.
- Minimum 3 years of experience in equipment qualification within the pharmaceutical industry.
- Proven hands-on experience executing IQ/OQ/PQ for manufacturing/process equipment (REQUIRED).
- Strong understanding of validation lifecycle, risk management, and qualification principles.
- Experience with deviations, investigations, and CAPA processes.
- Exposure to facilities or commissioning activities is a plus, but not the primary focus.
- Ability to sit for extended periods.
- Occasional light physical activity.
- Ability to work in manufacturing environments and use PPE as required.
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