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Validation Engineer II

Scorpion Therapeutics

Position Summary The Validation Engineer II generates and executes protocols, summary reports, and validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities with affected departments and personnel. Works under general supervision or mostly independently. Essential Functions Collaborate cross-functionally. Perform validation of equipment, utility systems, facilities, processes, and automation systems in compliance with SOPs, cGMPs, and regulatory requirements. Generate/support/execute IQ/OQ/PQ/CV/PV for site equipment (lab, production, utilities as applicable) in an FDA-regulated environment. Author/review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems. Maintain GMP system inventory and requalification/periodic review schedules. Perform/lead GMP risk assessments; plan validation efforts based on risk. Coordinate with clients, CMOs, and vendors; assist with vendor communications. Troubleshoot and resolve discrepancies during validation/qualification. Perform ad‑hoc/cross‑functional duties supporting business needs. Basic Qualifications Bachelor’s degree in science or related discipline. 3+ years validation or GMP-regulated industry experience. Experience with facility commissioning and validation of equipment/facilities. Preferred Qualifications Technical document writing/reviewing. Validation principles and commissioning; IQ/OQ/PQs. 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, communication, and organizational skills. Working Environment / Physical Environment On-site; in‑lab exposure; PPE required. Able to lift frequently up to 35 lbs; occasionally move 50 lbs. Benefits (eligible) Medical, dental, and vision plan options; wellness programs; EAP; life/AD&D and disability; FSAs; 401(k) match; 529; PTO (11 holidays for exempt/unlimited for exempt employees; specified vacation/personal days for non-exempt). #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 1 day ago
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