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
- Demonstrates knowledge of Standard Operating Procedures (SOPs)
- Demonstrates knowledge of Good Manufacturing Practice (GMP)
- Train new staff, as available
- Provide technical and project guidance to junior staff
- Participate in required safety, cGMP, and technical training sessions
Responsibilities include, but are not limited to:
- Performs, collects and analyzes simple validation data
- Collects and prepares preliminary reports
- Explore problems that occur and suggest appropriate solutions.
- Maintains files for validation documentation (i.e., IQ, OQ, PQ, and all other product changes)
- Routine maintenance of the R&D and manufacturing laboratory
- 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.