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Development Engineering

SK pharmteco

JOB SUMMARYThe Development Engineer III serves as an advanced individual contributor responsible for leading complex process development and scale-up activities for APIs and intermediates. This role independently drives technical solutions from laboratory through pilot and early commercial manufacturing, applying strong engineering judgment and cross-functional collaboration. This role level demonstrates deep technical capability, ownership of process strategy, and consistent contribution to commercial readiness and continuous improvement initiatives.DUTIES AND RESPONSIBILITIESLead design and execution of laboratory and pilot-scale experiments for reactions, extractions, distillations, crystallizations, filtrations, and drying operations.Develop and reconcile scalable mass and energy balances through commercial projection; validate assumptions with plant data.Serve as technical lead for assigned projects and provide clear process recommendations to stakeholders.Lead plant trials, demonstration campaigns, and first commercial batches; Partner with Manufacturing, Quality, EHS, and Supply Chain to ensure safe, compliant, and efficient scale-up.Evaluate reactive and hazardous materials, recommend mitigation strategies, and support hazard assessments (e.g., dust hazard data, reaction calorimetry).Support environmental permitting considerations and ensure adherence to GMP and company safety standards.Apply Quality by Design (QbD) principles, including design of experiments (DoE), definition of CPPs, and control strategy development.Analyze process data to support investigations, deviations, and continuous improvement initiatives.EDUCATION AND EXPERIENCE6-9 years of related experience and a bachelor's degree or 4-7 years of related experience and a master's degree or 1-4 years of related experience and a PhD in a related field.Bachelor's degree in Chemical Engineering or related engineering discipline required.COMPETENCIES/SKILLSStrong command of chemical engineering principles including mass and energy balances and scale-up methodology.Experience leading pilot or early commercial manufacturing campaigns.Working knowledge of GMP manufacturing and regulatory expectations.Proficiency in Microsoft Excel and technical data analysis tools.WORKING CONDITIONSOn-site laboratory, office and pilot plant. Shift coverage (day, swing, night) will be periodically required. Periodically participates in production support that may include nights, weekends, and holidays.This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy.This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role, consistent with applicable law.

Vacancy posted 5 days ago
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