Engineer, Validation

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

Job Description Header

Engineer, Validation in Boca Raton, FL!

Job Title: Engineer, Validation

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!

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), final reports, change controls, SOPs, deviations, etc.
• Manager, schedule, coordinate, and execute assigned qualification or validation activities to ensure timely completion of the validation plan in coordination with the system owner.
• 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.

Job Responsibilities Or Job Requirements

Competencies

FDA Adherence

Experience Requirements

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

Education Requirements:

Bachelor’s degree in science or engineering.

Preferred Experience

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.

Job Description Footer

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.