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Engineer, Validation

Employer
ADMA Biologics
Location
Boca Raton, FL
Start date
Sep 10, 2023

Job Details

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.

Company

ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.

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Company info
Website
Telephone
201-478-5222
Location
5800 Park of Commerce Blvd. NW
Boca Raton, FL 33487
US

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