Senior Validation Engineer – GMP Compliance Leader

cGMP Consulting Inc.; Joliet (IL); Presencial; USD 85.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

Paid time off

401K

Descripción de la vacante

cGMP Consulting Inc. seeks an experienced lead to manage GMP validation and qualification projects across equipment, utilities, facilities, systems, and processes. The role offers autonomy, leadership, and impact on cGMP manufacturing environments.

The candidate will guide cross-functional teams, handle complex troubleshooting, and ensure timely, compliant protocol execution in line with FDA and international standards.

Formación

• Bachelor's degree in Engineering, Science, or related field.
• 5+ years' GMP manufacturing experience.
• Experience drafting SOPs, protocols, and/or reports.
• Familiarity with FDA regulatory requirements.
• Experience with temperature validation equipment such as Temptales and Kaye.

Responsabilidades

• Lead development and authorship of URS, RA, FS for new processes, equipment and systems.
• Oversee engineering projects from concept to execution with technical direction.
• Coordinate equipment commissioning with cross-functional teams for validation readiness.
• Design, execute, and review complex validation/qualification studies for utilities, equipment, and processes.
• Manage multiple qualification initiatives and communicate with stakeholders to ensure alignment.
• Lead cross-functional meetings and document critical decisions and follow-ups.
• Contribute to CAPA planning and SOP revisions to ensure regulatory compliance.

Conocimientos

GMP manufacturing experience

Technical writing

Project leadership

Analytical problem solving

Educación

Bachelor's degree in Engineering/Science

Herramientas

Temptales

Kaye temperature validation

Descripción del empleo

cGMP Consulting Inc. seeks an experienced lead to manage GMP validation and qualification projects across equipment, utilities, facilities, systems, and processes. The role offers autonomy, leadership, and impact on cGMP manufacturing environments.

The candidate will guide cross-functional teams, handle complex troubleshooting, and ensure timely, compliant protocol execution in line with FDA and international standards.