DESCRIPTION

Validation Engineer
Location: Boca Raton, FL
Salary: $70K – $85K per year + Great Benefits
100% on-site position

Responsibilities

• Develop, review, and approved technical documents such as qualification protocols (IQ/OQ/PQ), final reports, change controls, SOPs, deviations, etc.
• Manager, schedule, coordinate, and execute assigned qualification or validation activities to ensure timely completion of the validation plan in coordination with the system owner. These qualification/validation activities include facilities, utilities, equipment, and computer systems.
• Support maintaining all process and laboratory equipment, facilities, and critical systems/utilities in a qualified/validated state.
• Assist in the investigation of deviations encountered during the execution of validation protocols and provide documentation to support such an effort.
• Reviews executed protocols for completeness, cGxP compliance, data acceptability, and data integrity.
• Supports the site periodic reviews and requalification programs.
• Works with other departments to troubleshoot equipment.
• Interact with FDA investigators regarding validation compliance issues and regulatory requirements.
• Coordinate and support validation activities with appropriate departments and contract validation firm employees.
• Monitor validation activities or contract employees assigned to validation projects.

Requirements

• Bachelor’s degree in science or engineering.
• 3+ years validation experience in a cGMP, Pharmaceutical/Biological manufacturing environment.
• strict adherence to FDA regulations and company policies governing sales and marketing activities.

Please apply with your updated resume.