CQV Lead

Job Description:
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 cGMP, 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.
• Requirements:
• 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.