Biopharma Validation Engineer — Ensure cGMP Compliance

ADMA BioCenters; Boca Raton (FL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

401K plan with employer match and IMed

Medical, Vision, Life and Dental

Pet Insurance

Company paid STD and LTD

Company Paid Holidays

3 Weeks’ Paid Time Off

Tuition Assistance (after the first年)

Free shuttle to Boca Tri-Rail

Job summary

ADMA Biologics in Boca Raton, FL seeks an Engineer, Validation to support Immunotherapy Production, Quality Control and Plant Engineering. The role ensures the validation plan meets regulatory standards and maintains all critical systems in a qualified state.

You will develop, review and execute IQ/OQ/PQ protocols, coordinate with departments and contract validation staff, and interface with FDA investigators on validation compliance.

Qualifications

• 3+ years validation experience in a cGMP, Pharmaceutical/Biological manufacturing environment.
• Bachelor’s degree in science or engineering.
• Experience with FDA regulations and regulatory compliance training is preferred.
• Proven ability to interact with FDA investigators on validation issues.

Responsibilities

• Develop, review, and approve qualification protocols (IQ/OQ/PQ), final reports, change controls, SOPs, deviations.
• Schedule, coordinate, and execute assigned qualification or validation activities to ensure timely completion of the validation plan.
• These qualification/validation activities include facilities, utilities, equipment, and computer systems.
• Support the validation strategy used at ADMA Biologics ensuring it is harmonized with regulatory standards and current good manufacturing practices.
• 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.

Skills

Validation experience

cGMP familiarity

Documentation

Regulatory compliance

Education

Bachelor’s degree in science or engineering

Job description

ADMA Biologics in Boca Raton, FL seeks an Engineer, Validation to support Immunotherapy Production, Quality Control and Plant Engineering. The role ensures the validation plan meets regulatory standards and maintains all critical systems in a qualified state.

You will develop, review and execute IQ/OQ/PQ protocols, coordinate with departments and contract validation staff, and interface with FDA investigators on validation compliance.