Process Engineer, Technical Operations - Small Molecule Drug Substance

Role: Process Engineer supporting API manufacturing at a small molecule biopharmaceutical facility, focused on technology transfer, validation, and commercial production. Responsibilities: provide technical support for process development (chemical synthesis, crystallization, drying), support scale-up and validation activities (pre-PPQ, PPQ), analyze process data for performance improvement, and collaborate on technology transfer and process optimization. Contribute to operational excellence, troubleshooting, deviation investigations, and compliance with cGMP standards. Collaborate cross-functionally with Manufacturing, R&D, Quality, and Engineering teams. Requirements: Bachelor’s in Chemical Engineering, Chemistry, or related; 2–5+ years in API manufacturing or process development; experience with process support, technology transfer, or manufacturing operations; understanding of cGMP. Key skills include data analysis, troubleshooting, problem-solving, and team collaboration. High-Value: small molecule APIs, process development, validation, technology transfer, commercial manufacturing, cGMP compliance, process optimization. Work setup: on-site with ~10% travel.