Development Engineering

Job Summary The Development Engineer II independently supports and executes process development and scale-up activities for APIs and intermediates. This role applies engineering principles to design, optimize, and troubleshoot chemical processes from laboratory through pilot and early commercial manufacturing. This role demonstrates growing technical depth, increasing ownership of assigned projects, and the ability to collaborate cross-functionally to support safe and efficient scale-up.
Duties and Responsibilities Design and execute laboratory and pilot-scale experiments for reactions, extractions, distillations, crystallizations, filtrations, and drying operations.
support commercial-scale projections.
Prepare process flow diagrams, material balances, and supporting technical documentation.
Support pilot plant campaigns and initial manufacturing batches, including monitoring critical process parameters.
Troubleshoot process issues during demonstration and first commercial runs.
Collaborate with Manufacturing, Quality, and EHS to ensure safe and compliant operations.
Identify potential safety risks related to chemical hazards, reactions, and processing steps and recommend mitigation strategies.
Review safety data (e.g., Support environmental and emissions documentation and ensure adherence to GMP and company safety standards.
Support Quality by Design (QbD) initiatives, including participation in design of experiments (DoE) and evaluation of critical process parameters (CPPs).
Analyze process data to support investigations and continuous improvement efforts.
Contribute to technical reports and project summaries for internal and client review.
Education and Experience 2-5 years of relevant process development or manufacturing experience;
Bachelor's degree in Chemical Engineering or related engineering discipline required.
Competencies/Skills Solid understanding of chemical engineering principles including mass and energy balances.
Experience with laboratory and pilot-scale unit operations.
Ability to independently analyze data and draw technical conclusions.
Proficiency in Microsoft Excel and basic data analysis tools.
Working Conditions On-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.

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