Validation Engineer (Pharmaceutical)

*CQV Specialist – Utilities | Pharmaceutical Manufacturing* *Location:* Juncos, Puerto Rico We are seeking an experienced *CQV Specialist – Utilities* to support commissioning, qualification, validation, and maintenance activities within a *GMP-regulated pharmaceutical manufacturing environment* in Juncos, Puerto Rico. The ideal candidate will have hands-on experience with *Commissioning, Qualification & Validation (CQV)* activities, GMP-regulated systems, validation protocols, technical documentation, investigations, and regulatory compliance. Experience supporting *non-critical utilities and utility system validation* is highly preferred. Key Responsibilities * Support *Commissioning, Qualification, and Validation (CQV)* activities for pharmaceutical manufacturing facilities and systems. * Develop, review, execute, and document qualification and validation activities in accordance with approved procedures and GMP requirements. * Support preparation and execution of *URS, Design Specifications (DS), IQ, OQ, and PQ protocols*. * Review engineering and design documentation to ensure systems are appropriately qualified and meet intended use requirements. * Support validation activities associated with *non-critical utilities and facility systems*. * Assist with commissioning activities, system start-up, testing, troubleshooting, and qualification. * Prepare and execute qualification protocols and associated test scripts. * Document test results, discrepancies, deviations, and qualification findings. * Support *deviation investigations, root-cause analysis, CAPA activities, and validation reports*. * Prepare and review technical documentation, reports, protocols, and other GMP records. * Ensure CQV documentation is complete, accurate, traceable, and compliant with applicable *cGMP and regulatory requirements*. * Work closely with Engineering, Facilities, Manufacturing, Quality, Validation, and other cross-functional teams. * Provide technical support during project execution and system qualification activities. * Participate in project meetings, design reviews, field activities, and technical investigations. * Ensure all activities are performed in accordance with approved procedures, regulatory requirements, and industry best practices. * Support maintenance and continued qualification activities as required. * Work extended hours, including *weekends and holidays*, when required by project schedules. Required Qualifications * Bachelor's degree in *Engineering, Life Sciences, Chemistry, Biology, Pharmacy, or a related technical discipline* preferred. * Hands-on experience in *Commissioning, Qualification, Validation (CQV), equipment qualification, or pharmaceutical validation*. * Experience working in a *GMP/cGMP-regulated pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment*. * Strong understanding of *cGMP/cGxP requirements and regulatory guidance*. * Hands-on experience developing and/or executing: * *URS – User Requirements Specifications* * *DS – Design Specifications* * *IQ – Installation Qualification* * *OQ – Operational Qualification* * *PQ – Performance Qualification* * Experience with *validation protocols, execution, documentation, and final reports*. * Experience with *deviations, investigations, discrepancies, and root-cause analysis*. * Strong *technical writing and documentation* skills. * Proficiency with *Microsoft Office and Windows-based applications*. * Ability to work effectively within a *multidisciplinary pharmaceutical project environment*. * *Fluent/bilingual in English and Spanish*, with strong verbal communication skills. Pay: $34.91 - $45.89 per hour Work Location: In person