Engineer, Validation

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

Benefits offered by this job

401K with match

Medical Insurance

Vision Insurance

Dental Insurance

Life Insurance

STD/LTD

Holidays

Paid Time Off

Tuition Assistance

Shuttle service

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Validation

cGMP

Documentation

Regulatory compliance

Education

Bachelor's degree in science or engineering

Job description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands‑on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Engineer, Validation in Boca Raton, FL!

Job Title: Engineer, Validation

Position Summary

The Engineer, Validation provides validation support to Immunotherapy Production, Quality Control and Plant Engineering. This role also provides activity updates to Validation Manager on a regular basis to ensure compliance issues are being met.

Essential Functions (ES) and Responsibilities

• Develop, review, and approved technical documents such as qualification protocols (IQ/OQ/PQ), finalreports, change controls, SOPs, deviations, etc.
• Manager, schedule, coordinate, and execute assigned qualification or validation activities to ensuretimely completion of the validation plan in coordination with the system owner.
• Thesequalification/validation activities include facilities, utilities, equipment, and computer systems.
• Support the validation strategy used at ADMA Biologics ensuring it is harmonized with regulatorystandards and current good manufacturing practices.
• Support maintaining all process and laboratory equipment, facilities, and critical systems/utilities in aqualified/validated state.
• Assist in the investigation of deviations encountered during the execution of validation protocols andprovide 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 firmemployees.
• Monitor validation activities or contract employees assigned to validation projects

Competencies

FDA Adherence

Experience Requirements

Education Requirements: Bachelor’s degree in science or engineering.

Experience Requirements: 3+ years validation experience in a cGMP, Pharmaceutical/Biological manufacturing environment.

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 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. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.