Validation Engineer

Location
Boca Raton, FL
Posted
Jul 13, 2021
Ref
27353
Required Education
Bachelors Degree
Position Type
Full time

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!

 

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
  • Responsible for all aspects of Validation from start to finish, including establishing, managing, and maintaining a scientifically sound validation program including; temperature mapping, qualification of equipment, instruments, and utilities.

 

  • Write, review and execute validation protocols for product manufacturing and Quality control.  Including analysis and review of test data results.

 

  • Responsible for summarizing results and conclusions when writing final reports.  Ensure final reports and study data is reviewed and approved in a timely manner after execution is completed.

 

  • Coordinate and schedule re-qualification activities with appropriate departments.

 

  • Assist in the investigation of deviations encountered during the execution of validation and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation.

 

  • Responsible for overall supervision and oversight during execution of validation activities.

 

  • Write and provide training on SOPs relevant to validation procedures.

 

  • 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.

 

  • Knowledgeable of current FDA guidelines and industry standards pertaining to validation.

 

  • Assist in writing regulatory documents for FDA submission.

 

  • Interact with FDA investigators regarding validation compliance issues and regulatory requirements.

 

 

Education Requirements:                                 

Bachelor’s degree in Science or Engineering.

 

Experience Requirements:                                

Three to five years validation experience in a cGMP, Pharmaceutical/Biological manufacturing environment.

 

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.