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.