Validation Specialist

Description

• Generate, execute and summarize validation documentation for process equipment qualification
• Lead Validation/Qualification/CSV efforts for equipment purchased or modified (FAT, SAT, OQ, PQ)
• Coordinate with Quality, technical scientists, and vendors for validation protocols, execution, and final reports
• Generate, execute and summarize project plans, conduct and peer review change controls, review validation related exceptions events, as well as provide input to site as a SME
• Contribute to the development and revision of validation concepts, techniques, and standards to ensure compliance with regulatory requirements.
• Assist in validation related issue resolutions for all GMP laboratory equipment
• Generate and participate in any change control activities as required
• Participate in any tasks associated with system implementation or upgrades as required
• Lead/support periodic and data integrity reviews
• Participate, support, and drive Continuous Improvement initiatives
• All other duties as assigned

Qualifications

• Bachelor’s Degree in Life Sciences, Physical Science, or Engineering field
• Minimum 2 years of relatable experience within a laboratory, validation, or quality environment
• Prior cGMP experience highly preferred