CQV Lead

Job Title: CQV LeadLocation: Davie, FLDuration: 9 + months (Temp to perm: Possible based on openings and performance)Shift Schedule: Monday - Friday 8.00AM to 5.00PMPosition Summary:We are seeking a CQV Lead with hands-on experience in Oral Solid Dose (OSD) manufacturing who brings both strong engineering fundamentals and a modern, digital-first approach to validation delivery.This role is intended for engineers who own qualification outcomes end-to-end—from interpreting design intent to defining critical parameters, executing risk-based protocols, and ensuring systems consistently perform within validated ranges. The CQV Lead will drive commissioning, qualification, and validation of manufacturing equipment, utilities, facilities, and computerized systems, ensuring compliance with cGMP, FDA, and data integrity expectations.Key Responsibilities:CQV Leadership & Execution:Lead commissioning, qualification, and validation (CQV) activities for OSD manufacturing and packaging equipment, facilities, utilities, and computerized systems.Develop and execute risk-based IQ/OQ/PQ protocols aligned to critical quality attributes (CQAs) and critical process parameters (CPPs).Lifecycle & Compliance Management:Lead or support change control, deviation investigations, and CAPA implementation.Ensure alignment with cGMP, FDA regulations, and 21 CFR Part 11 expectations for computerized systems.Technical Problem Solving:Troubleshoot equipment, utilities, and automation interfaces (PLC/SCADA/historian integrations) impacting qualification outcomes.Minimum Requirements:Master’s or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related) with 3+ years of experienceTechnical & Functional Competencies:Strong understanding of OSD unit operations and equipment (e.g., blending, granulation, compression, coating, encapsulation, and relevant automation including historian).Familiarity with automation systems (PLC/SCADA) and data historians (e.g., PI).