CQV Lead

Job Summary:

We are seeking a CQV Lead (OSD Manufacturing) with strong engineering fundamentals and hands-on experience in commissioning, qualification, and validation within a GMP-regulated Oral Solid Dose (OSD) environment. This role involves leading end-to-end CQV activities for manufacturing equipment, packaging systems, utilities, facilities, and computerized systems. The ideal candidate will combine deep technical expertise with a modern, digital-first approach to validation, ensuring systems are compliant, reliable, and inspection-ready. The CQV Lead will collaborate closely with cross-functional teams including QA, Automation, Engineering, and Manufacturing to deliver validated systems aligned with FDA, cGMP, and data integrity standards.

Roles & Responsibilities:

CQV Leadership & Execution Lead commissioning, qualification, and validation (CQV) activities for OSD manufacturing and packaging systems Develop and execute risk-based

IQ/OQ/PQ

protocols aligned with critical quality attributes (CQAs) and critical process parameters (CPPs) Translate URS, FS/DS, and design specifications into testable acceptance criteria Evaluate system performance, operational ranges, and process reliability Digital Validation & Documentation Utilize digital tools and structured templates to efficiently generate validation documentation (protocols, reports, RTMs) Perform thorough technical review and approval of all validation deliverables Ensure compliance with data integrity principles (ALCOA+) and Good Documentation Practices (GDP) Maintain inspection-ready documentation at all times Lifecycle & Compliance Management Maintain validated state through lifecycle management, periodic reviews, and requalification activities Lead/support change controls, deviation investigations, and CAPA implementation Ensure compliance with c

GMP, FDA

regulations, and 21 CFR Part 11 requirements Technical Problem Solving Identify critical parameters, control strategies, and challenge system design assumptions Troubleshoot issues related to equipment, utilities, and automation systems (PLC/SCADA, data historians) Cross-Functional Collaboration Partner with QA, MS&T, Automation, and Manufacturing teams for project execution and compliance readiness Communicate technical risks, timelines, and decisions effectively

Education & Experience:

Master's or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related field) with 3+ years of relevant experience Hands-on CQV experience in a GMP-regulated Oral Solid Dose (OSD) manufacturing and/or packaging environment Proven experience in authoring and executing

IQ/OQ/PQ

protocols and validation reports Experience with Computerized System Validation (CSV), data integrity, and 21 CFR Part 11 compliance Strong understanding of OSD unit operations such as blending, granulation, compression, coating, and encapsulation Familiarity with automation systems (PLC/SCADA) and data historians (e.g., PI) Ability to interpret mechanical, electrical, and control system designs Excellent technical writing, analytical, and problem-solving skills Experience using digital validation tools and structured documentation systems is preferred