Biopharma Validation Engineer — Systems & Compliance

ADMA Biologics, Inc.; Boca Raton (FL); Vor Ort; USD 85.000 - 120.000; Vollzeit

Benefits dieser Stelle

401K with match

Medical Insurance

Vision Insurance

Dental Insurance

Life Insurance

STD/LTD

Holidays

Paid Time Off

Tuition Assistance

Shuttle service

Zusammenfassung

ADMA Biologics, Inc. in Boca Raton, FL is seeking an Engineer, Validation to support Immunotherapy Production, Quality Control, and Plant Engineering. This role ensures compliance with validation protocols and maintains validated state of facilities and equipment.

Requirements include a Bachelor's degree in science or engineering and 3+ years of validation experience in a cGMP setting. Strong documentation, regulatory coordination, and FDA interaction skills are essential.

Qualifikationen

• Bachelor’s degree in science or engineering is required.
• 3+ years of validation experience in a cGMP, pharmaceutical/biological manufacturing environment.
• Strong documentation and regulatory coordination skills are essential.

Aufgaben

• Develop, review, and approve qualification protocols (IQ/OQ/PQ) and related documents.
• Coordinate and execute qualification/validation activities to meet the validation plan.
• Support validation strategies aligned with regulatorystandards and cGMP.
• Maintain equipment and systems in a qualified/validated state.
• Assist investigations of deviations and provide supporting documentation.
• Interact with FDA investigators regarding validation compliance.

Kenntnisse

Validation

cGMP

Documentation

Regulatory compliance

Ausbildung

Bachelor's degree in science or engineering

Jobbeschreibung

ADMA Biologics, Inc. in Boca Raton, FL is seeking an Engineer, Validation to support Immunotherapy Production, Quality Control, and Plant Engineering. This role ensures compliance with validation protocols and maintains validated state of facilities and equipment.

Requirements include a Bachelor's degree in science or engineering and 3+ years of validation experience in a cGMP setting. Strong documentation, regulatory coordination, and FDA interaction skills are essential.