Engineer, Validation

Job DetailsLevel ExperiencedJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeTravel Percentage NegligibleJob Shift DayJob Category EngineeringDescription

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 a Validation Engineer in Boca Raton, FL!

 

The Validation Engineer will provide validation support to Immunotherapy Production, Quality Control and Plant Engineering.  Provide activity update of Validation Manager on a regular basis to ensure compliance issues are being met. 

Qualifications

• Interact with FDA investigators regarding validation compliance issues and regulatory requirements.
• Develop, write and execute equipment, cleaning and utility system validations for product manufacturing and support processes.
• Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, and P&Ids, as they relate to validation and regulatory compliance issues.
• Coordinate validation activities with appropriate departments and contract validation firm employees.
• Assist in the investigation of deviations encountered during the execution of validation protocols and provide documentation to support such an effort.
• Monitor validation activities or contract employees assigned to validation projects.
• Write and provide training on SOPs relevant to Validation procedures.
• Assist in writing regulatory documents for FDA submission.
•  Prepare annual evaluation and operational assessment reports of critical systems and equipment for review and final approval.
• In the absence of Validation Manager, serves as Validation Services representative in staff meetings and other validation-related meetings.

 

Education Requirements:                                 

Bachelor’s degree in Science or Engineering is required.

 

Experience Requirements:                                

Three years of validation experience in a cGMP, Pharmaceutical, Biological, or Manufacturing environment is required. 

 

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
• Company paid shuttle to the Boca Tri-Rail station

 

ADMA Biologics, Inc. 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.