Validation Engineer for Biotech Production & Compliance

ADMA Biologics; Boca Raton (FL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

401K with employer match

Medical, Vision, Life and Dental

Pet Insurance

STD and LTD

Holidays

Paid Time Off

Tuition Assistance

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. You will manage qualification/validation activities and ensure FDA-compliant documentation and data integrity, working with cross-functional teams.

The role focuses on maintaining validated state of facilities, utilities, equipment, and critical systems, while coordinating with contract validation firms and internal departments.

Qualifications

• Experience in a cGMP, Pharmaceutical/Biological manufacturing environment.

Responsibilities

• Develop, review, and approve qualification protocols (IQ/OQ/PQ) and related documentation.
• Schedule and execute qualification/validation activities with system owners.
• Support validation strategies aligned with regulator standards and cGMP.
• Maintain equipment, facilities, and systems in validated state.
• Assist investigations of deviations and provide supporting documentation.
• Interact with FDA investigators regarding validation compliance.

Skills

FDA Adherence

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. You will manage qualification/validation activities and ensure FDA-compliant documentation and data integrity, working with cross-functional teams.

The role focuses on maintaining validated state of facilities, utilities, equipment, and critical systems, while coordinating with contract validation firms and internal departments.