Validation Engineer

Overview

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 science/engineering field and 1 to 2 years of equipment qualification/validation experience

• Ability to understand and demonstrate knowledge of Standard Operating Procedures (SOPs).
• Demonstrates knowledge of Good Manufacturing Practice (GMP) and FDA 21 CFR 210/211/820, EU GMP Annex 1, ICH guidelines.
• Hands-on experience with Kaye validator and temperature mapping.
• Soft skills such as technical writing, good communication skills, root-cause investigation and cross-functional coordination skills, detail-oriented mindset.

• Author I/O/PQ protocols, periodic review documents, specifications, SOPs and summary reports.
• Maintain and execute equipment periodic review activities for various departments equipment and systems including Facilities, Environmental Monitoring, Bioassay, Manufacturing and Quality Control.
• Co-ordinate with various departments and stakeholders to gather information and documentation related to the equipment and systems.
• Assist in specifying and selecting equipment. Maintains all records related to qualification and validation.
• Prepare periodic review and validation summary reports and make recommendations for modifications as necessary.
• Initiate and maintain Deviation and CAPA activities and perform any corrective actions as needed.

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 to  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.