Pharma Validation Facility Engineer

About the role

Lead engineering, maintenance, and validation activities within a clinical packaging environment.

Tasks

• Lead capital projects, engineering activities, and technical support initiatives in collaboration with internal teams and external vendors.
• Manage equipment, facility, utility, and cleaning validation activities to ensure compliance with pharmaceutical quality and regulatory standards.
• Develop, maintain, and update Validation Master Plans (#VMPs) and oversee validation change control documentation.
• Prepare, review, execute, and approve validation lifecycle documentation using a Validation Management System (#VMS).

Requirements

• Minimum of 5 years of combined experience in pharmaceutical validation, engineering, maintenance, or related technical roles within the pharmaceutical industry.
• Hands-on experience preparing, reviewing, and executing validation documentation using a #VMS.
• Knowledge of equipment qualification, facility and utility validation, cleaning validation, and change control.
• Experience developing and maintaining Validation Master Plans (VMPs).
• Working knowledge of pharmaceutical packaging equipment, equipment reliability, and clinical packaging operations.
• Preferred: Experience managing capital projects and validation improvement initiatives.
• Preferred: Experience supporting pharmaceutical quality audits and regulatory compliance activities.
• Preferred: Proven ability to coordinate cross-functional teams, supervise engineering technicians, and manage external validation resources.
• Bachelor's degree

Location

• #Cincinnati, OH, Katalyst Pro