Senior Validation Engineer & Packaging Equipment Lead

Katalyst-Healthcares-; Cincinnati (OH); On-site; USD 100,000 - 150,000; Full time

Job summary

Katalyst-Healthcares is seeking a Validation Engineer to lead validation activities in a clinical packaging area. You will oversee capital projects, coordinate with operations, engineering services, and vendors, and manage the Validation Master Plan to ensure compliance with standards and quality expectations.

The role requires strong knowledge of validation documents (VMS) and collaboration with Quality and Operations to optimize processes, improve efficiency, and maintain product quality

Qualifications

• Bachelor's Degree in an engineering discipline.
• 5+ years combined work experience in validation and/or engineering within the pharmaceutical area.
• Experience creating and executing validation documents in VMS.
• Knowledge of Client engineering and financial systems.
• Understanding of Client Engineering Standards and Specifications.
• Understanding of pharmaceutical packaging equipment.

Responsibilities

• Manage all departmental capital projects and coordinate services.
• Lead equipment, facility, utility and cleaning validation activities.
• Maintain the Validation Master Plan and Validation Change Control.
• Identify opportunities to reduce costs and increase capacity via process improvements.
• Represent department in quality audits regarding validation and engineering compliance.
• Supervise engineering technicians and manage resource allocation.
• Collaborate with Operations and Quality through Validation Review Boards.

Skills

Validation

Engineering

Quality systems

Process improvement

Education

BS in engineering

Tools

VMS

Client systems

Engineering standards

Job description

Katalyst-Healthcares is seeking a Validation Engineer to lead validation activities in a clinical packaging area. You will oversee capital projects, coordinate with operations, engineering services, and vendors, and manage the Validation Master Plan to ensure compliance with standards and quality expectations.

The role requires strong knowledge of validation documents (VMS) and collaboration with Quality and Operations to optimize processes, improve efficiency, and maintain product quality