Sr Engineer, PD Process Validation & Business Strategy

SR. ENGINEER, PD PROCESS VALIDATION & BUSINESS STRATEGY What You Will Do Lead the development of Process Validation/Process Performance Qualification strategy for New Products, aligned with regulatory guidelines and industry standards. Apply upstream (cell culture) and downstream (purification) bioprocessing knowledge to support process validation, technology transfer, and plant start-up. Lead execution of validation projects/protocols and collect data to complete process validation activities. Provide cross-functional process monitoring support as needed. Guide generation, resolution, and closure of deviations. Lead ANC PD business strategy activities to improve network practice, develop digital tools, and optimize ANC PD business operations. Ensure safety and compliance of process development activities. Provide process validation floor process support as required. Lead process validation support for regulatory filing, inspection, and other CMC activities. Basic Qualifications High school diploma/GED and 10 years of biologics process development/engineering/validation experience; OR Associate’s degree and 8 years; OR Bachelor’s degree and 4 years; OR Master’s degree and 2 years; OR Doctorate degree. Preferred Qualifications 5+ years in process validation or downstream (purification) role in regulated (cGMP) biopharmaceutical manufacturing. Strong upstream/downstream manufacturing expertise. Validation experience including PPQ, master plans, protocols, and reports. Ability to multi-task and work in teams; demonstrated leadership and decision-making. Experience with scale-up, technology transfers, EBRs, deviations, CAPA, and change control. Excellent oral and verbal communication with diverse stakeholders. Benefits Total Rewards Plan: health/welfare plans, retirement savings plan, bonus/incentive, stock-based long-term incentives, time-off plans, and flexible work models where possible. #J-18808-Ljbffr Scorpion Therapeutics