Senior Validation Engineer - Packaging & Equipment Lead

Regulatory Jobs; Cincinnati (OH); Presencial; USD 110.000 - 170.000; Jornada completa

Descripción de la vacante

AbbVie seeks a Senior Validation Engineer to lead maintenance, validation, and engineering activities in the clinical packaging area. You will supervise equipment, facilities, utilities, and cleaning validation, coordinating with Operations, engineering services, and vendors to ensure product quality and regulatory compliance.

The role requires a BS in engineering, 5+ years of validation/engineering experience in pharma, and familiarity with validation documentation, VMS, and AbbVie standards.

Formación

• 5+ years combined experience in validation and/or engineering in the pharmaceutical sector.
• Experience creating and executing validation documents in VMS.
• Familiarity with AbbVie engineering standards and specifications.
• Understanding of pharmaceutical packaging equipment.

Responsabilidades

• Manage all departmental capital projects and coordinate services with vendors.
• Lead equipment, facility, utility and cleaning validation activities.
• Maintain the Validation Master Plan (VMP) and change control docs.
• Identify cost-reduction, flexibility, and capacity-improvement opportunities.
• Interface with Operations and Quality through Validation Review Boards.
• Ensure validation documentation integrity through reviews.
• Investigate and resolve validation-related issues promptly.
• Lead quality improvement projects to ensure regulatory compliance.
• Represent department in internal and external audits.

Conocimientos

Validation

Engineering

GxP

VMS

Educación

Bachelor’s Degree in Engineering

Herramientas

VMS

Descripción del empleo

AbbVie seeks a Senior Validation Engineer to lead maintenance, validation, and engineering activities in the clinical packaging area. You will supervise equipment, facilities, utilities, and cleaning validation, coordinating with Operations, engineering services, and vendors to ensure product quality and regulatory compliance.

The role requires a BS in engineering, 5+ years of validation/engineering experience in pharma, and familiarity with validation documentation, VMS, and AbbVie standards.