CQV Lead

Shift Schedule: Monday - Friday 8.00AM to 5.00PM
Duration: 9 + months
Temp to perm: Possible based on openings and performance

Core essential skill sets:
1. Minimum Masters or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related) with 3+ years of experience
2. Hands-on CQV experience in a GMP Oral Solid Dose (OSD) facility supporting manufacturing and/or packaging operations.
3. Proven experience developing and executing IQ/OQ/PQ protocols and final reports in regulated environments.
4. Experience with Computerized System Validation (CSV), data integrity, and 21 CFR Part 11 compliance.
5. Strong understanding of OSD unit operations and equipment (e.g., blending, granulation, compression, coating, encapsulation and relevant automation including historian).
6. Ability to interpret mechanical, electrical, and control system designs and identify critical parameters.
Familiarity with automation systems (PLC/SCADA) and data historians (e.g., PI).
Excellent technical writing skills with a focus on inspection-ready documentation.
Ability to analyze complex systems, assess risk, and drive data-based decisions.

Position 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-endfrom 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.
Beyond execution, this role requires the ability to leverage digital tools and automation to improve the speed, quality, and traceability of validation deliverableswhile maintaining full technical ownership of the final output. The candidate must be comfortable using automated/structured tools to generate draft documentation, and then independently reviewing, challenging, and approving content to ensure engineering accuracy, completeness, and regulatory defensibility.
The ideal candidate holds a Masters or PhD in an Engineering discipline and demonstrates deep, hands-on CQV experience on the floorunderstanding OSD unit operations, equipment design, integrated controls, and GMP documentation expectations. This role partners closely with QA, Automation, Engineering, and Manufacturing to deliver compliant, reliable, and inspection-ready systems.
________________________________________
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).
Translate URS, FS/DS, and design intent into testable and traceable acceptance criteria.
Evaluate system performance, operational ranges, and process reliability using sound engineering principles.

Digital Validation & Documentation Ownership
Utilize digital tools and structured templates to generate qualification documents efficiently (protocols, reports, traceability matrices).
Perform rigorous manual technical review and approval of all generated content to ensure accuracy, completeness, and compliance.
Ensure all executed evidence meets data integrity (ALCOA+) and GDP standards, and is inspection-ready.
Lifecycle & Compliance Management
Maintain validated state through lifecycle management, periodic reviews, and requalification decisions.
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
Identify and challenge critical parameters, control strategies, and system design assumptions.
Troubleshoot equipment, utilities, and automation interfaces (PLC/SCADA/historian integrations) impacting qualification outcomes.
Cross-Functional Delivery
Partner with QA, MS&T, Automation, and Manufacturing teams to ensure successful project execution and inspection readiness.
Provide clear communication of risks, timelines, and technical decisions.
________________________________________
Minimum Requirements
Masters or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related) with 3+ years of experience
Hands-on CQV experience in a GMP Oral Solid Dose (OSD) facility supporting manufacturing and/or packaging operations.
Proven experience developing and executing IQ/OQ/PQ protocols and final reports in regulated environments.
Experience with Computerized System Validation (CSV), data integrity, and 21 CFR Part 11 compliance.
________________________________________
Technical & Functional Competencies
Strong understanding of OSD unit operations and equipment (e.g., blending, granulation, compression, coating, encapsulation and relevant automation including historian).
Ability to interpret mechanical, electrical, and control system designs and identify critical parameters.
Familiarity with automation systems (PLC/SCADA) and data historians (e.g., PI).
Excellent technical writing skills with a focus on inspection-ready documentation.
Ability to analyze complex systems, assess risk, and drive data-based decisions.