Senior Operations Engineer - API

Role: Senior Operations Engineer supporting API small molecule manufacturing startup, overseeing commissioning, qualification, start-up, and operational readiness at a new Elkton, VA facility. Responsibilities: partner with cross-functional teams (Operations, Engineering, Quality, Supply Chain) to ensure safe, compliant, and efficient plant start-up; support process transfer, troubleshooting, and optimization; help define and improve operating procedures; utilize lean tools (Kaizen, 5S, visual management) to drive continuous improvement; act as delegate for Production Lead and promote safety, quality, and operational excellence. Requirements: Bachelor's degree in Chemical, Pharmaceutical, Biochemical Engineering, Chemistry or related; minimum 5 years in API small molecule manufacturing, with experience in operations or technical support; knowledge of GMP, quality, compliance; strong problem-solving and collaboration skills; able to work in a fast-paced environment. Preferred: experience with commissioning, qualification, validation, greenfield startup, lean methodologies, cross-shift coordination, and leadership support roles. HighValue: small molecule APIs, API manufacturing, plant startup, GMP compliance, process support, cross-functional collaboration. WorkSetup: onsite in Elkton, VA, with 10% travel.