Validation Engineer IV/Specialist

Overview

The Validation Engineer IV assists the Validation Director in protocol generation, performs the qualification of equipment and systems and writes detailed reports to document the qualification. This individual maintains qualification and requalification schedules, and provides validation support for facility and utilities, compliance upgrades, analytical instruments, and GXP software.    

Responsibilities

• Conduct qualification of systems/equipment in Celldex facilities
• Maintains documentation pertaining to qualification and validation
• Revise procedures and/or protocols as assigned
• Assist or provide oversight to validation contractors and vendors
• Assist in the development of Validation schedules in conjunction with the functional groups
• Compile and analyze validation data, and prepare reports
• Investigate and troubleshoot problems which occur and determine solutions
• Act independently to determine methods and procedures on new assignments
• Supervises the activities of other lower-level personnel as assigned
• Off-hours work may be required, as assigned, to support validation projects
• Limited travel may be required to other Celldex sites or companies which provide contract services to Celldex
• May be involved or be assigned the development of validation programs and procedures
• Leads validation projects and acts as the Validation Department representative on teams or site meetings

Qualifications

• Associate degree or certificate, Bachelor Science degree in biological sciences, engineering, or related discipline
• 10 years of Validation experience in biologics/biotech industry
• Knowledge of FDA regulations, European Directives, ICH guidelines, and cGMP regulations
• Strong written and interpersonal communication skills
• Strong knowledge of MS Word, and Excel