Lead Validation Engineer – Clinical Packaging & Compliance

SmartRecruiters, Inc.; Cincinnati (OH); In loco; USD 85.000 - 162.000; Tempo pieno

Descrizione del lavoro

AbbVie is seeking a Senior Validation Engineer to lead maintenance, engineering, and validation activities in the clinical packaging area.

The role partners with Operations and external vendors to ensure product quality and regulatory compliance, and requires 5+ years in pharma validation. This position is based in the United States with a focus on high-throughput packaging facilities.

Competenze

• Bachelor's degree in engineering required.
• 5+ years in validation or engineering in the pharmaceutical sector.
• Experience creating and executing validation documents in VMS.
• Knowledge of AbbVie engineering and financial systems.
• Understanding AbbVie engineering standards and pharmaceutical packaging equipment.

Mansioni

• Manage all departmental capital projects and coordinate services with vendors.
• Handle equipment, facility, utility and cleaning validation activities.
• Maintain the Validation Master Plan and Change Control documentation.
• Identify cost-saving and capacity-improvement opportunities.
• Ensure validation documentation quality and timely issue resolution.
• Represent the department in internal and external quality audits.
• Supervise engineering technicians and contract validation staff.
• Collaborate with cross-functional teams to support clinical studies.
• Initiate changes to SOPs to support processes.
• Balance short-term support with long-term departmental objectives.

Conoscenze

Validation experience

Pharma industry knowledge

Project coordination

Formazione

Bachelor's Degree in Engineering

Strumenti

VMS

Descrizione del lavoro

AbbVie is seeking a Senior Validation Engineer to lead maintenance, engineering, and validation activities in the clinical packaging area.

The role partners with Operations and external vendors to ensure product quality and regulatory compliance, and requires 5+ years in pharma validation. This position is based in the United States with a focus on high-throughput packaging facilities.