The role involves participating in qualifying and validating brand-new process engineering equipment and facilities, promoting continuous improvement and innovation within a regulated GMP environment.
Responsibilities
Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems and ongoing SLC support post-implementation.
Supervise and resolve deviations, manage changes (GEP and GMP), and implement CAPAs effectively.
Coordinate efforts between internal teams and external service providers and suppliers to ensure seamless project execution.
Present qualification documents during audits and inspections, showcasing the outstanding standards maintained.
Responsible for commissioning, qualification and validation (CQV) activities, including document development and testing execution to meet client qualification needs.
Locations (2)
Conshohocken, Pennsylvania, United States
Indiana, United States
Responsibilities
Performs work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS)
Demonstrates an understanding of project scope of work assigned
Demonstrates an understanding of commercial aspects (hours and capital cost) of their work
Delivers scope of work within budgeted hours
Document development as well as testing execution to meet client qualification needs
Requirements
Bachelor’s degree
Nice to have: engineering degree
Nice to have: knowledge of cGMP manufacturing environments
CQV Engineer II responsible for commissioning, qualification, and validation activities, document development, and testing execution to meet client qualification needs.
Compensation
The pay range for this position is $85,000 – $105,000 annually.
Responsibilities
Performs work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS)
Demonstrates an understanding of project scope of work assigned
Demonstrates an understanding of commercial aspects (hours and capital cost) of their work
Delivers scope of work within budgeted hours
Document development as well as testing execution to meet client qualification needs
Participation au développement de systèmes de drones militaires (MTO) incluant l'intégration, vérification, validation et qualification, de bench tests to real-world condition trials.
Responsibilities
Réaliser les activités d'intégration, de vérification, validation et de qualification (IVVQ), conformément au plan de tests défini.
Contribuer aux essais sur banc, notamment aux tests de non-régression et à la validation des évolutions du système.
Participer aux essais terrain, notamment aux essais en vol, ainsi qu'aux démonstrations auprès des clients.
Rédiger les rapports d'essais afin de formaliser les résultats des activités de vérification et de validation.
Renseignez et suivre les indicateurs de performance (KPI) des activités IVVQ, contribuant au reporting du projet.
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