Validation Engineer I

Position Summary The Validation Engineer I is responsible for generating and executing protocols, creating summary reports, and executing validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through constant communication with affected departments and personnel; supports senior staff on low complexity projects. Essential Functions Support collaboration with cross‑functional departments, clients, CMOs, and vendors. Assist with validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with SOPs, cGMPs, and regulatory requirements. Generate, support, and execute validation protocols (IQ/OQ/PQ/CV/PV) for site equipment (lab/production), utilities (as applicable), and related systems. Maintain inventory of GMP systems and requalification/periodic review schedules. Perform risk assessments for GMP systems. Plan validation efforts according to risk. Troubleshoot validation/qualification discrepancies; assist senior engineers with resolutions. Support validation team purchasing and oversee supplies/equipment inventory. Adhere to SOPs; support process improvements and template standardization. Perform ad‑hoc/cross‑functional duties and/or projects as assigned. Basic Qualifications Bachelor’s degree in a science or related discipline (required). 1+ years validation or GMP-regulated industry experience (required). Facility commissioning and validation of equipment/facilities experience (required). Preferred Qualifications Technical document writing/reviewing. Validation principles and industry standards. Commissioning and IQ/OQ/PQ knowledge for equipment/facilities. Quality systems knowledge: change control; CAPA (deviations/OOSs); training; document control. GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing, and plant equipment. Interpersonal, independent/teamwork, communication, and organizational skills. Benefits Medical, Dental, Vision Plan Options Health and Financial Wellness Programs EAP Life/AD&D Short/Long-Term Disability Flexible Spending Accounts 401(k) match 529 Education Savings Paid Time Off (11 holidays; unlimited PTO for exempt employees; vacation/health/personal/cultural day details for non-exempt) Application Instructions Application window: anticipated to close 60 days from posting (or sooner if filled/closed). #J-18808-Ljbffr