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Validation Engineer

CEL-SCI Corporation
Elkridge, MD
Start date
Jul 21, 2022

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Engineering, Validation Engineer
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

Department: Research and Development

The Validation Engineer is responsible for the regulation and support of equipment and systems. Assists in equipment selection, specification, and negotiating fees. Maintains all records related to qualification and validation. Works on projects where data analysis requires evaluation of defined factors to broad concepts. Utilizes independent judgment within broad parameters to determine an appropriate solution.  Prepares validation reports, suggests and assists in determining specifications, and makes recommendations for modifications as necessary.  The Validation Engineer reports to the Validation Supervisor.


  • B.S. in a related discipline and 1 to 5+ year of relevant experience
  • M.S. in a related discipline and 2 to 4 years of relevant experience
  • Ph.D. in a related discipline and 1 to 2 years of relevant experience


  1. Demonstrates knowledge of Standard Operating Procedures (SOPs)
  1. Demonstrates knowledge of Good Manufacturing Practice (GMP)
  2. Train new staff, as available
  3. Provide technical and project guidance to junior staff
  4. Participate in required safety, cGMP, and technical training sessions

Responsibilities include, but are not limited to:

  1. Performs, collects and analyzes simple validation data
  2. Collects and prepares preliminary reports
  3. Explore problems that occur and suggest appropriate solutions. 
  4. Maintains files for validation documentation (i.e., IQ, OQ, PQ, and all other product changes)
  5. Routine maintenance of the R&D and manufacturing laboratory
  6. Draft/revise SOP’s, Testing Standards, Specifications, Training Guidelines, and other documentation


Position is full time.

This position may require periodic local travel between CEL-SCI Facilities, to contract facilities, and to external Validation providers. 


Baltimore & Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.  

Please submit cv/resume and cover letter .  Reference the job title in the subject line of the email  


CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.


CEL-SCI Corporation is a pioneer in cancer immunotherapy. We are a clinical-stage biotechnology company focused on finding the best way to activate the immune system to fight cancer, infectious and autoimmune diseases. CEL-SCI believes that boosting a patient's immune system before surgery, radiation and chemotherapy should provide the greatest possible impact on survival since that is the time when the immune system is the strongest. Therefore, in the Phase 3 clinical study CEL-SCI treated patients who were newly diagnosed with head and neck cancer with Multikine immunotherapy right after diagnosis, BEFORE they went on to receive surgery, radiation and/or chemotherapy. This approach is unique since cancer drugs are mostly given after surgery, radiation and chemotherapy have failed. The Phase 3 study is the largest ever in head and neck cancer with 928 patients enrolled. It reached the targeted threshold required to conduct data evaluation and is currently in the statistical analysis phase. Head and neck cancer represents about 6% of all cancers worldwide and an unmet medical need. Multikine has received Orphan Drug designation from the FDA for this indication. CEL-SCI operates its own 73,000 sq. ft. GMP manufacturing facility that produces Multikine and a separate research & development laboratory that supports the manufacturing of Multikine. CEL-SCI has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Stock Symbol: CVM

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Find Us
(703) 506-9460
8229 Boone Boulevard
Suite 802
United States
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