CQV Lead

Katalyst CRO; Town of Florida (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in the United States is seeking a CQV Lead (OSD Manufacturing) with strong engineering fundamentals and hands-on CQV experience in a GMP-regulated Oral Solid Dose environment. You will lead end-to-end CQV activities for manufacturing equipment, packaging systems, utilities, facilities, and computerized systems to ensure validated, inspection-ready state.

The role emphasizes a digital-first approach to validation, collaboration with QA, Automation, Engineering, and Manufacturing, and

Qualifications

• Master's or PhD in Engineering with 3+ years CQV in GMP OSd environments
• Proven ability to author IQ/OQ/PQ protocols and validation reports
• Experience with CSV, data integrity, and 21 CFR Part 11 compliance

Responsibilities

• Lead CQV for OSD manufacturing and packaging systems
• Develop risk-based IQ/OQ/PQ protocols aligned with CQAs and CPPs
• Translate URS, FS/DS, and design specs into acceptance criteria
• Evaluate system performance, ranges, and reliability
• Utilize digital tools to generate validation documentation (protocols, reports, RTMs)
• Maintain inspection-ready documentation at all times
• Lead/change controls, deviations, and CAPA in a CGMP/regulatory context
• Collaborate with QA, Automation, Engineering, and Manufacturing teams

Skills

CQV leadership

GMP compliance

OSD manufacturing

IQ/OQ/PQ protocols

CSV

Data integrity

Technical writing

PLC/SCADA

Cross-functional collaboration

Education

Master's or PhD in Engineering

Tools

PI Data Historian

PLC/SCADA

Job description

Job Summary

We are seeking a

• 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

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 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

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