Instrument and CSV Engineer I

Job description

Core Hours Monday - Friday, 8:00 am - 5:00 pm Purpose and Scope: The Instrument and CSV Engineer I supports laboratory instruments and computer systems validation activities under general supervision. This role focuses on documentation, protocol execution, and learning regulatory expectations. Essential Duties & Responsibilities: - Assist in developing and executing validation deliverables (IQ/OQ/PQ) for lab instruments and GxP computer systems including upgrades and revalidation. - Work with instrumentation and computer system vendors to verify validation criteria and data integrity requirements are met. - Support data collection, deviation documentation, and report generation for the Validation team. - Follow established procedures and templates for validation deliverables. - Complete assigned change actions for validation projects within defined timeframes. - Participate in instrument and system testing and verification activities. - Collaborate with QA, laboratory staff and IT to ensure compliance with 21 CFR Part 11 and data integrity and regulatory standards. - Adheres to company and departmental timelines with high accuracy and quality. - Maintain an atmosphere of teamwork,...