Validation Engineer
About the role
The Validation Engineer is responsible for the regulation and support of equipment and systems, assisting in equipment selection, specification, and negotiating fees. This role involves maintaining all records related to qualification and validation, working on projects requiring data analysis, and utilizing independent judgment to determine appropriate solutions. The Validation Engineer prepares validation reports, suggests specifications, and makes recommendations for modifications as necessary, reporting to the Validation Supervisor.
Responsibilities
- Author I/O/PQ protocols, periodic review documents, specifications, SOPs, and summary reports.
- Maintain and execute equipment periodic review activities for various departments, including Facilities, Environmental Monitoring, Bioassay, Manufacturing, and Quality Control.
- Coordinate with departments and stakeholders to gather information and documentation related to equipment and systems.
- Assist in specifying and selecting equipment.
- Maintain all records related to qualification and validation.
- Prepare periodic review and validation summary reports and recommend modifications as necessary.
- Initiate and maintain Deviation and CAPA activities and perform corrective actions as needed.
Requirements
- B.S. in a science or engineering field.
- 1 to 2 years of equipment qualification/validation experience.
Skills
- Understanding and knowledge of Standard Operating Procedures (SOPs).
- Knowledge of Good Manufacturing Practice (GMP), FDA 21 CFR 210/211/820, EU GMP Annex 1, and ICH guidelines.
- Hands-on experience with Kaye validator and temperature mapping.
- Technical writing, communication, root-cause investigation, and cross-functional coordination skills.
- Detail-oriented mindset.
Schedule
This is a full-time position. Periodic local travel between CEL-SCI facilities, contract facilities, and external validation providers may be required.
Pay and Benefits
We offer competitive salaries, comprehensive benefits, and Employee Stock Options.
Location: Baltimore & Elkridge, MD