Job Description
Job Description
Job Summary We are seeking a CQV Lead with hands-on experience in Oral Solid Dose (OSD) manufacturing who combines strong engineering fundamentals with a modern, digital-first approach to validation delivery. This role is responsible for end-to-end qualification outcomes, ensuring manufacturing equipment, utilities, facilities, and computerized systems consistently perform within validated ranges while meeting cGMP, FDA, and data integrity expectations.
Key Responsibilities
- Lead CQV activities for OSD manufacturing and packaging equipment, facilities, utilities, and computerized systems.
- Develop and execute risk-based IQ/OQ/PQ protocols aligned with CQAs and CPPs.
- Translate design intent into testable acceptance criteria and traceability matrices.
- Utilize digital tools to generate qualification documents efficiently, followed by rigorous technical review.
- Ensure executed evidence meets ALCOA+ and GDP standards, maintaining inspection-ready documentation.
- Maintain validated state through lifecycle management, periodic reviews, and requalification.
- Support change control, deviation investigations, and CAPA implementation.
- Troubleshoot equipment, utilities, and automation interfaces impacting qualification outcomes.
- Partner with QA, Automation, Engineering, and Manufacturing teams to ensure compliant project execution.
Required Qualifications
- Master’s or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related).
- Minimum of 3 years of CQV experience in a GMP Oral Solid Dose (OSD) facility.
- 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.
Preferred Qualifications (if any)
- Strong understanding of OSD unit operations and equipment (blending, granulation, compression, coating, encapsulation).
- 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.
Certifications (if any)
- None required; certifications in validation, quality, or project management are advantageous.
Education: Masters Degree
Company DescriptionCompunnel Inc., established in 1994; is a leading provider of Staffing, IT/Software, e-Learning/Training, Business Intelligence, and Cloud Solutions. A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based/SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments. Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia. As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.
We have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year. Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US. We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national/ethnic region, disability, or any other basis.
Company Description
Compunnel Inc., established in 1994; is a leading provider of Staffing, IT/Software, e-Learning/Training, Business Intelligence, and Cloud Solutions. A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based/SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments. Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia. As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.\r\n\r\nWe have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year. Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US. We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national/ethnic region, disability, or any other basis.