Engineer, Validation

About the role

ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. The Engineer, Validation provides validation support to Immunotherapy Production, Quality Control and Plant Engineering, ensuring compliance with regulatory standards and current good manufacturing practices.

Responsibilities

• Develop, review, and approve technical documents such as qualification protocols (IQ/OQ/PQ), final reports, change controls, SOPs, and deviations.
• Manage, schedule, coordinate, and execute assigned qualification or validation activities to ensure timely completion of the validation plan in coordination with the system owner.
• Support the validation strategy at ADMA Biologics to ensure harmonization with regulatory standards and cGMP.
• Maintain 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 supporting documentation.
• Review executed protocols for completeness, cGxP compliance, data acceptability, and data integrity.
• Support site periodic reviews and requalification programs.
• Work 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

• Education: Bachelor’s degree in science or engineering.
• Experience: 3+ years of validation experience in a cGMP, Pharmaceutical/Biological manufacturing environment.

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail with free shuttle to the Boca Tri-Rail station