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.
Bachelor’s degree in Science or Engineering.
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.