Validation Engineer

POSITION SUMMARY:

The Validation Engineer provides support to the Quality Assurance Department by performing and/or coordinating validation and calibration activities in accordance with FDA and other applicable regulatory requirements. The Validation Engineer is responsible for equipment, system, cleaning and software qualification/validation activities. The Validation Engineer is responsible for ensuring that equipment and systems remain in a validated and/or calibrated state.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•Participating in Process Equipment Commission Activities
•Developing URS and FRS
•Maintaining Facility VMP and CVMP
•Determining Qualification/Validation for GxP Equipment
•Generating/Executing Protocols (IQ, OQ, PQ) and Generating Summary Report
•Change Control Validation Representative
•Maintaining Calibration Equipment Database
•Generating Calibration Specifications
•Maintaining any calibration reference standards
•Coordinating or performing routine and non-routine calibration activities
•OOT Program Management
•Maintaining spare/back up calibration equipment
•Other duties as assigned
REQUIREMENTS
QUALIFICATIONS AND REQUIREMENTS:

•Bachelor of Sciences degree in Engineering or related and three+ years of experience in a Validation Technician role within a GMP environment
•Must have hands-on experience in some of the following areas: Determining Validation Requirements, Protocol Generation, Protocol Execution, Report Generation, Validated System Change Control, GMP manufacturing, Operating equipment such as: Kaye Validator, thermocouples and Valprobes. ETOP and Facility Commission, Calibration Program Management, Calibration Specification Development and Contractor Oversight
•Software Validation, Test Script Generation, Review and Execution
•Good understanding of FDA regulations (biologics or drugs)
•Project Management Experience
•Detail-oriented with good verbal and written communications skills; demonstrated ability to manage multiple projects/tasks
•Ability to analyze data for accuracy and correctly interpret results
•Microsoft Office experience